Importance of Packaging Machine in the Pharmaceutical Industry

Have you ever wondered the sanitary and efficiency of your medicines while you make the purchase in pharmacy? The various packaging machines in the pharmaceutical industry make the important work to convey the clean and efficient medical products to many patients.

Have you ever wondered the importance of packaging machine in pharmaceutical industry? Do you know the frequently used packaging machines in the pharmaceutical industry? How to find your suitable packaging machine in pharmaceutical industry? Here is the answers about all above questions.

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1.What IsPackaging Machine In The Pharmaceutical Industry?

Pharmaceutical Packaging-Sourced:arka

For the pharmaceutical products, the unqualified and normal packaging may lead the damage of products in transporting and change effect for medical use. Pharmaceutical packaging is the special packaging for the reliable and sanitary protection of medical products and other products for pharmaceutical use.

The packaging machines in the pharmaceutical industry have various type and strict standard for the production of hygienic and protective pharmaceutical products. For different type and dosage, the packaging methods are different and you may see the various types of packaging machines in the pharmaceutical industry.

2.What Are The Common Packaging Material For Pharmaceutical Packaging Use?

For different packaging manner, there is different packaging material adopted to pharmaceutical packaging use.

Plastic

Plastic Material-Sourced:stringentdatalytics

Plastic material is one of the most common packaging material for pharmaceutical use. You may see the bottle, sachet, suppository and so many material for pharmaceutical use. Plastic material is cheap and can make the efficient and protective packaging for various types of material.

Glass

Glass Material-Sourced:glassproduct

Glass is the irreplaceable material for injecting medicine packaging. Its durability and great resisting to acid and alkalis make it also the important packaging material to some special medical products. Ampoule, vial and many medical packaging all need the application of glasses in it.

Aluminum

Aluminum Material-Sourced:aluminumfoil

Aluminum can be frequently found in blister packaging in pharmaceutical industry. The softness, flexibility and durability of aluminum make it the ideal packaging material for pack the capsule, soft gel and many other medical products. You may also see its use in sealing tube and so on.

Paper

Paper Material-Sourced:cdnbestsuppliers

Paper is usually used for sealing small sachet. The low price and anti light make it the great material for many medical products. And most importantly, it can make the sustainable and bio degradable work. For the final tertiary packaging, it can also makes the great carton for your medicine packaging.

3.What Are The Packaging TypesFor The Pharmaceutical Industry?

As there are various types of medicines in pharmaceutical industry, there are also various packaging types for you to choose. Here are the representative packaging types for pharmaceutical industry.

Blister packaging

Blister Packaging-Sourced:sedpharma

Blister packaging is one of the most common packaging type for pharmaceutical industry. For various tablet, capsule and soft gel, it can make the safe, air tight and protective packaging. The fragile products like medical devices or equipment can also be protected well from blister packaging.

Bottle packaging

Bottle Packaging-Sourced:dynamicmedia

Bottle packaging has a wide range. You may find the bottle packaging of various type from small bottle and big bottle. From the packaged material, it can also differed greatly. Which is your packaged material, syrup, air drop or other? The different packaged material should apply the different packaging machine type.

Sachet packaging

Sachet Packaging-Sourced:aranow

Sachet packaging is also a widely applied packaging type. The packaging of medical products into the sachet is cost effective and protective. The medical and herb powder is one type which adopts the sachet packaging most frequently. For granule, powder or some liquid sachet packaging is the recommended packaging way.

Tube packaging

Tube Packaging-Sourced:mplusa

Tube packaging is the packaging which suits the topical used medicines like cream, ointment, lotion and so on. The tube packaging can prove the efficiency and sanitary of packaged material greatly. And it can also make the more accurate and precise caring for some small zone for your skin or other places.

Suppository packaging

Suppository Packaging-Sourced:saintyco

Suppository packaging is the special packaging to make the suppository. Its packaging manner is different and makes the great benefits to some special medicine. Suppository gets into people’s body from rectum, vagina or urethra and melt when meeting your body temperature.

Vial and ampoule packaging

Vial And Ampoule Packaging-Sourced:uskbalaji

Vial and ampoule packaging is the packaging which is widely used in injection area. The medicine injection should be with the highest hygienic standard. And now the vial and ampoule packaging can also be used in wound caring, skin caring and so on for its great feature in sanitary and conserving.

4.What Are The Representative Packaging Machines In The Pharmaceutical Industry?

The pharmaceutical packaging machines are various. And here are some representative packaging machines which are used in pharmaceutical industry.

Blister packaging machine

ALLPAK Blister Packaging Machine

Blister packaging machine usually packs the capsules and tablets to make the airtight clean environment for the various medical products. Besides the common capsule and tablet, you may also see its use in medical equipment. It can make various form and size for the different need and requirement.

Strip packaging machine

ALLPAK Strip Packaging Machine

Strip packaging machine is used in pharmaceutical industry to pack the pill, tablet, capsule and so on. The preventing of pollution in the single strip intervals makes sure the great effect and sanitary of your medical products. The machines can pack the strip with high efficiency and great flexibility and you may also see its use in food, cosmetic and other industry.

Liquid filling machine

ALLPAK Liquid Filling Machine

Liquid filling machine packs the various liquids for pharmaceutical industry. It can handle the various packaging from vial filling, syrup filling, spray filling, eye drop filling and so on. The high request on the medical products like iodine, alcohol and so on can be satisfied by it. The great sanitary, large bulk and efficiency makes it outstanding in liquid filling of pharmaceutical industry.

Powder filling machine

ALLPAK Powder Filling Machine

Powder is also the frequently used medicine form in pharmaceutical industry. The powder filling machine packs various medical products like glucose, medical solids and so on. It can perform a series of work like separating, filling, locking and so on. For powder of various type and size, it can all handle.

Granule packaging machine

ALLPAK Granule Packaging Machine

Granule packaging machine can pack the various granule. You may see its frequent use in medicine-dissolved medicine and Chinese herb medicine. Granule is the important medical form in pharmaceutical industry. The granule packaging machine can assure the sanitary and efficiency of the whole packaging process.

Tablet packaging machine

ALLPAK Tablet Packaging Machine

Tablet packaging machine can count and pack various medicine form. And you may find the packaging of the various specification of tablets, capsules, soft gelatin capsules and other small medical devices. It can also make the mix packaging for nutrition pack. The great protection and showing of medical products make this packaging form so popular.

Capsule filling machine

AIPAK Capsule Filling Machine

Capsules are one of the most common medical dosage in pharmaceutical industry. Capsule filling machine should take the strict work to deal with different kinds and fine powder and granule. Capsule filling machine is a practical machine which can make the fluent and nice packaging work for various form and particles.

Tube filling machine

ALLPAK Tube Filling Machine

For pharmaceutical industry, there is the requirement for tube filling as the topical medicine like ointment and cream need the tube for accurate transferring. Tube filling machine makes the excellent work in packing ointment, pasta and various medical products into tube for pharmaceutical use.

Suppository filling machine

ALLPAK Suppository Filling Machine

Suppository can make the effective and useful delivering of medical effect for human. It makes great help for the patients who may be hard to take drug and medicines which are unsuitable for the stomach’s environment. Suppository filling machine makes the series of reliable work to make suppository with various shapes.

5.Importance Of Packaging Machine In The Pharmaceutical Industry

Packaging machine is irreplaceable in pharmaceutical industry and its importance cannot be underestimated. Here is the importance of packaging machine in pharmaceutical industry.

Accuracy and consistency

Consistency-Sourced:brainzmagazine

Packaging machines make the consistent and precise packaging. The right and precise packaging is rather important for various medical products. The wavering of the dosage in some kind may lead the change of effect. Packaging machines make the great job in making the accurate packaging which is needed for pharmaceutical industry.

Efficiency

Efficiency-Sourced:revechat

Packaging machines reduce the work of labor and make the packaging work with high efficiency. For the large production, it needs the high efficient packaging machine to make the timely production and make the organized managing. This can save their time and save more for business.

Automation

Automation-Sourced:mida

The high automation of pharmaceutical packaging machine helps reduce the human mistake and prove the sanitary on packaging process. The high automation pharmaceutical packaging machine take can also prove the high speed processing of the whole packaging process.

Quality prove

Quality Prove-Sourced:idexxcurrents

Packaging machine used in pharmaceutical industry can prove the products’ quality. The packaging process with little joining of human has smaller chance to be contaminated. And you may control the quality of the packaging products better from packaging machine rather than the labor work.

Regulatory compliance

Regulatory Compliance-Sourced:finreg-e

The pharmaceutical products are tested and inspected carefully as it makes so much important work for people. And the changing and advancing regulatory compliance needs the flexible packaging machine for pharmaceutical use. The adoption of packaging machine can improve traceability and offer reporting for the prove of products and business quality.

Better protection

Better Protection-Sourced:maidsbytrade

The packaging machines makes better packaging work. The packaging are made with series of strict packaging process and passes the test and check of packaging machine. The little adding of human and great packaging work can prove the better protection of machine in transporting and storing.

Anti counterfeiting

Anti Counterfeiting-Sourced:temera

The labeling and packaging work of packaging machines for pharmaceutical industry can make the great anti counterfeiting job. The tracing and reporting packaging machine offered is the great method for anti counterfeiting. For the labor work with low automation, the anti counterfeiting is impossible.

Cost saving

Cost Saving-Sourced:optimizemro

Packaging machines in the pharmaceutical industry is a big cost for pharmaceutical business. But in a long ran, it improves the packaging efficiency and improves the profitability. For the better qualified products made from pharmaceutical packaging machine, your business can make the better marketing work.

6.What Other Industry Can The Packaging Machine In The Pharmaceutical Industry Be Applied?

Packaging machines can be used in more than one places. What other industry can packaging machine be applied? Here are some representative industries which adopt the packaging machine frequently.

Food industry

Food Industry-Sourced:entrepreneurialchef

For food industry, there are also the high standard on food safety and packaging efficiency. The application of packaging machine in food industry can prove the quality of food. It can also make the various and attractive packaging which may promote sale in market.

Cosmetic industry

Cosmetic Industry-Sourced:somewang

Cosmetic products have also the the high sanitary request on cosmetic products packaging. The efficient packaging work can maintaining the efficiency of essence, lotion and other skin relative products. The reliable packaging can also prove the material which contact people’s skin.

Chemical industry

Chemical Industry-Sourced:gamerpackaging

The chemical products also have a wide application in our life. The chemical products have various form in our life and you may see iron, gas, plaints and so on. The packaging of chemical products should be clean and air tight for the pollution and deterioration for the further use.

Supplementary industry

Supplementary Industry-Sourced:trackmind

Supplementary industry is a blooming industry in current world. Vitamin, mineral, herb and so much supplementary products are waiting for the the clean and reliable packaging. You may see its various forms like tablet, capsule, pill, gummy and so on which all need the various packaging form for its nice transporting to market.

Agricultural industry

Agricultural Industry-Sourced:Packagingoftheworld

There are fertilizers, nutrition and so many other chemical products serving for agricultural industry. The packaging for agricultural industry should be stable and strong. The packaging form for agricultural industry should also be various for the various type. And you may see the packaging for tablet, powder and so on.

7.What You Should Consider For The Suitable Packaging Machine In The Pharmaceutical Industry Purchase?

Packaging machines for pharmaceutical use take the important role in pharmaceutical industry. But for so many different pharmaceutical packaging machine, what you should consider for the suitable machine purchase.

Cost

Cost

Cost-Sourced:hypergene

Cost is your first consideration for the suitable pharmaceutical packaging machine purchase. You should make clear your business’s condition and your business’s future developing road. The too much cost on pharmaceutical packaging machine purchase is a burden for your business rather than the help.

Product type

Product Type-Sourced:sgs

Tablet, capsule, powder or gummy, what is your product type? For different product type, you should get the relative machine. The powder filling machine should used for powder filling and eye drop filling machine for eye drop. The misuse of capsule filling machine for gummy packing may make big mistake.

Product capacity

Product Capacity-Sourced:mrpeasy

Product capacity is also the important factor for you to consider. The machine type can show machine’s capacity and performance. How much do your business need? Your machine should make the products which suit the need of your productivity. The type which is short in capacity can benefit your business no more.

Machine quality

Machine Quality-Sourced:highqualitymachine

Machine quality is the important factor for you to consider. The unqualified machine may make a series of mistakes in the manufacturing process and hinder your process. To choose the packaging machine with good quality, you should get the big brand and have a deep knowing about the machine judges, machine processing and machine quality.

Compatibility

Compatibility-Sourced:nsrd

You should investigate the features of your medical products with the different pharmaceutical machine. Will your packaging machine and packaging material affect each other? The compromising of the both can make the suitable and qualified products for your business.

Durability and sustainability

Durability And Sustainability-Sourced:amtonline

The products made from your pharmaceutical packaging machine should be durable and qualified for the long and complicated transporting and storing road. And your pharmaceutical packaging machines should also be able to make the sustainable products for the benefit of flexible packaging solution.

Automation line

Automation Line-Sourced:quickpakinc

Automation which improves the efficiency greatly is now the inescapable topic in our pharmaceutical industry. For the automated packaging line, you should make clear the automation level of your packaging machine for later automation packaging line forming.

Regulatory standard

Regulatory Standard-Sourced:fairinstitute

The medical products should get through series of inspecting for the suitable use. And there are various regulatory standard for different country and different medicines. To make your medicine circulate wide and smooth, you should make clear the local regulatory standard for the pharmaceutical packaging machine choose.

8.What Other MachineCan Support Packaging In The Pharmaceutical Industry?

After you have packaged your medicine products well, what else you should do? Your machine in this state cannot go on market yet. Here are the machines which can support your later pharmaceutical packaging.

Labeling machine

ALLPAK Labeling Machine

For better anti counterfeiting and propaganda, there should be label on medical products packaging. There are various labeling machine for you to choose and you may find the wrap-around labeling machine, automatic ampoule labeling machine, bottle labeling machine, double-sided labeling machine, top sticker labeling machine.

Cartoning machine

ALLPAK Cartoning Machine

The well packaged medical products need the tertiary packaging for the safer transporting and protecting in conveying and storing. The cartoning machine is thus essential equipment for the further support of your pharmaceutical packaging.

Flow wrapping machine

AIPAK Flow Wrapping Machine

You may find the plastic filming seal for your well packaged products while you shopping in market. The flow wrapping machine give your packaged medical products the direct protecting from dust or light. It can also support your pharmaceutical packaging work in many way.

9.What Is The Future Trend Of Packaging Machine In The Pharmaceutical Industry?

The packaging machines in the pharmaceutical industry are made more and more advance in current time. And there are the clear future trend for the packaging machine in pharmaceutical industry.

Customization

Customization-Sourced:istockphoto

The future packaging machine in pharmaceutical industry should be customized for the various packaging products and packaging performance need. The customized packaging machine should be highly efficient and automated for the dealing with various kinds of products.

Intelligence

Intelligence-Sourced:nubrickpartners

The intelligence and automation of packaging machine can be further updated. The joining of people in packaging process will be less. The high automation with great intelligence can make the great work which improves efficiency and saves labor working.

Sustainability

Sustainability-Sourced:businessreporter

In future pharmaceutical packaging, the concerning on sustainable and eco-friendly will be greater. And your packaging solution should also be sustainable and eco-friendly for the environment and safer use.

Conclusion

The importance of packaging machine in the pharmaceutical industry is obvious. The selection of the packaging machine which suits your pharmaceutical business can benefit you in an all around way. If you have any problem or questions, do not hesitate to contact ALLPAK now.

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Drug Vs Medicine: What’s The Difference?

Pharmaceutical Standard

Drug Vs Medicine: What’s The Difference?

Drugs and medicines are the two terms which are frequently used interchangeably. But in actual, it's not the case! You may be among one of them who up till now considered both the same. Well, you are not alone. In fact most of the individuals in pharmaceutical field also do the same. So, we have come up with this precise review that will simply explore Drug Vs Medicine: What's The Difference?

It is necessary to mark difference between both as misunderstanding can lead us to generate wrong concepts. Thus, from the meaning till their history, purpose, and formulations everything will be covered about drug and medicine. In addition to it, the blog will also touch areas like therapeutic effects. So, be ready to give it a thorough read!

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1.What Are Drugs?

Drugs

Recreational drugs- Picture Courtesy: iStock

Drugs can be defined as chemical substances obtained from plants and animal sources. They are essential to bring the desired change in body such as physiological or mental change. However, the effect of drugs can be seen both in positive and negative way.

Thus, we may conclude drug as powerful material that can be used to treat certain illnesses and diseases without any fix outcome. Drugs are also used in making medicines as active pharmaceutical ingredients. That's why, it is said that all medicines are drugs but not all drugs are medicines.

2.What Are Medicines?

Various medicines- Picture Courtesy: Shutterstock

Medicines refer to the formulated medications used for curing and preventing certain diseases like cancer, hepatitis, and diabetes etc. Medicines are available in different forms such as solid dosage form including tablets and capsules or liquid dosage form like syrups and vaccines.

Unlike drugs, medicines have defined outcomes in form of therapeutic effects and possible side effects. Similarly, they are made by combining together active pharmaceutical ingredients and excipients for stable medicine administration in body.

3.Drug Vs Medicine: What's The Difference?

Although, drug and medicine is often used synonymously but both of them vary in multiple aspects. To make the difference more clear for you, we have highlighted few notable areas which are as follows:

Meaning

The term drug is originated from French word "drogue" which means "dry herbs". It signifies plant sources which were preferred by ancient people to treat health disorders. Thus, it can be said that drugs are original and primary substances which are used for generating physiological effects.

On the other hand, the word medicine is derived from Latin word "medicina" meaning "to heal" or "a physician". It demonstrates that a physician heal the patients by prescribing medicines.

History

History

Evolution of medicine- Picture Courtesy: openmedscience.com

Human history is such a beautiful and horrible chapter that uncover the surprising discoveries about drugs. As first humans were haunter-gatherers, they used to check different plants and animals for their effects. The beneficial substances were then identified and documented from generation to generation. The early writings about drugs trace back to 3000 BC and 4000 BC in China.

Medicines have been discovered over the course of history being started from ancient Greece in around 2700 BCE. Hippocrates is called the "Father of Medicine" I the inherent age. However, the modern medicine development is occured during 17th century.

Purpose

Purpose

Patient taking capsules with glass of water- Picture Courtesy: garmeylaw.com

Drugs are taken for two reasons: either for treatment or for personal pleasure. From this, the purpose of drugs can be simply understood which is to relieve pain and bring desired physical and mental change.

While as, the sole purpose of medicine is to eliminate particular disease and manage health condition.

Components

Various components of drug & medicine- Picture Courtesy: arkbh.com

Drug is a single component with no specific dose. It is referred to as the active pharmaceutical ingredient which has the potential to generate desired effect.

In contrast, medicine is a formulation of active pharmaceutical ingredients along with excipients to produce stable dosage form.

Sources

Sources

Plant sources of drug & medicine- Picture Courtesy: garudahealth.org

Drugs are obtained from multiple sources which are either natural or synthetic. The common examples include plants, animals, minerals, and microorganisms.

On the other hand, the source of medicine is drug combined with excipients which are inactive ingredients.

Side Effects

Side effects of drug & medicine- Picture Courtesy: painscale.com

Drugs do have potential side effects which can be harmful and may go to extreme level if dosage is increased. Commonly, these side effects are same for all kinds of patients.

However, the side effects of medicines vary from person to person. It is because every individual has different system to process the medicine and react with it. Thus, allergic reaction and other symptoms may or may not occur.

4.Types Of Drug Vs Medicine?

Drugs and medicines can be categorized into various types on the basis of their effects and formulations respectively. These types are mentioned below:

Drugs

Opioids

Opioid- Picture Courtesy: nursingcenter.com

It refers to the class of drug which is derived from opium. Such drugs are used as pain relievers and used both legally and illegally.

Depressants

Patient with depressant drugs- Picture Courtesy: medicalnewstoday.com

Depressant drugs are also called downers due to their function of reducing stimulation in nervous system. In this way, these drugs keep the brain calm and relax. It is important to note that minimal doses of depressants is useful, however, excessive amount can lead to serious condition like death.

Stimulants

Stimulants- Picture Courtesy: primroselodge.com

As the name indicates, stimulants is a group of drugs made for stimulating by accelerating the messages flow between brain and body. Thus, a person feel more energized and alert. However, overdose can lead to adverse reaction like anxiety.

Party Drugs

Hallucinogens- Picture Courtesy: libertyhouseclinic.co.uk

It is another powerful category of drug class that change the person's perception and interpretation of external world. It is considered the most dangerous drug type as the sense of reality changes. Hallucinogens and stimulants are the common examples.

Inhalants

Patient holding inhaler near mouth- Picture Courtesy: familyhealthdiary.co.nz

Inhalants are substances that are taken by mouth or through sniffing. They absorb very quickly into bloodstream as a result of which a person feel high. The common examples include volatile solvents, aerosol sprays, gases, and nitrites etc.

Prescription Drugs

Doctor prescribing drugs to patient- Picture Courtesy: theconversation.com

Prescription drugs are prescribed by doctors which are not harmful if taken as per suggestions. These drugs include pain killers and sleeping pills.

Medicines

Tablets & Pills

Tablets & pills- Picture Courtesy: healthnews.ng

Tablets and pills are solid dosage forms. They are made by compressing powder, granules, or pellets. With small to large size, easy drug administration, and stable dissolution, tablets and pills are popular medicine types. Effervescent tablets, sublingual tablets, and coated tablets are the common examples.

Capsules

Hard gel capsules- Picture Courtesy: gelita.com

In addition to tablets and pills, capsules constitute an important category of medicines. These include softgel and hard gel capsules. The former is used for encasing liquid medication, while as, the later is frequently used to deliver solid medication.

Syrups

Syrups

Syrup dispensing into spoon- Picture Courtesy: recnotes.com

Medicines are also produced in liquid form such as syrups and suspension etc. They are often used to aid convenient way of medicine taking instead of swallowing large and oversized pills.

Patches

Patches

Women pasting a medicated patch over affected area on hand- Picture Courtesy: istockphoto.com

Certain medicinal substances are also given through patches. These sticky patches, when applied to the external part of body, relieve pain and cure injury by infusing the medicine.

Injection

Doctor filling injection from vaccine vial- Picture Courtesy: hopkinsmedicine.org

Injection is another type of liquid medicine which is often inserted into body instead of oral consumption. The use of vaccines through injection is the notable example.

Topical Solutions

Ointment- Picture Courtesy: istockphoto.com

Such type of medicines are made in semi-liquid form like gels, ointments, and cream etc., which are spread and applied over affected area for cure.

Dissolving Strips

Woman keeping oral strip over tongue- Picture Courtesy: wellbeingnutrition.com

Medicines are also available in form of strips such as oral strips. These strips are simply placed in the mouth which dissolve with saliva.

Suppositories

Doctor holding a suppository in hand- Picture Courtesy: researchdive.com

Suppositories are among other types of medicines which carry good proportion of medicine. These suppositories are in solid form but melt down quickly due to body temperature. Examples include rectal suppositories, vaginal suppositories, and urethral suppositories.

5.Uses Of Drug Vs Medicine?

Liquid & powder drugs- Picture Courtesy: havendetoxne.com

Drug is a broad category which is taken in both sense like medical and non-medical. Similarly, its use is intended to treat diseases, while at the same time, people use it for recreational activities in parties which leads to drug abuse. Thus, drugs are used for both therapeutic and non-therapeutic use.

On the other hand, medicines are only developed for positive effects like antibiotics, pain killers, and insulin etc. These medicines are targeted to eliminate specific diseases. Hence, medicines have only therapeutic use.

6.Social Impact Of Drug Vs Medicine?

Boy with stop drug banner- Picture Courtesy: refocus.com.au

Both drugs and medicines have far reaching social impacts. It can be explained under following headings:

Positive Impact:

As far as the positive social impacts are concerned, so, medicines help in the management of healthy environment by provision of good treatment to individuals. By the effective use of medicines, chronic and unconventional diseases can easily tackled, leading to safety and enhanced mortality.

Similarly, drugs are useful to calm down a triggered nervous system and help in stimulating desired physical and mental effects.

Negative Impact:

Constant use of drugs badly impact the society. It causes social unrest due to increase in violence as the drug users show abnormal behavior. Overall, it is the root cause for drug abuse and enhanced crime rate.

Conclusion

To summarize, Drug Vs Medicine: What's the difference? is an important question about which we should have information. That's why, this blog highlighted the key differences between drug and medicine from their literal meaning till usage, history, and popular types. Although, both have positive social impacts, but over use especially of drugs can leave catastrophic effects at large. Thus, it is necessary to consider these facts in mind and always look for a safe and suitable way. If you are eager to learn more about similar topics, then visit our website!

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ISO For Pharma: The Complete FAQ Guide In 2024

Pharmaceutical Standard

ISO For Pharma: The Complete FAQ Guide In 2024

Whether you are running a pharmaceutical industry for a long period of time or new in the field, skipping to know about ISO For Pharma is no exception! Since, the concerned area is supposed to carry out precise, hygienic, and safe processing, compliance to quality standards like ISO become inevitable. Similarly, most of the manufacturers find it hard to get all the necessary information about ISO For Pharma.

ISO

Thus, we are here to address your concerns. After reading this in-depth FAQ guide, you will be able to comprehend what basically ISO For Pharma means. Not only this, but how can you get the certification for your company, what are its benefits, which areas it covers and much other aspects. So, no need to fret, just stay calm and dive deep into this review!

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1.What Is Meant By ISO For Pharma?

ISO for pharma illustration- Picture Courtesy: pharmaoffer.com

ISO, International Organization for Standardization, is a global body that establishes rules and regulations for certifying goods and products. These principles provide a strong check to produce safe and quality products. With presence in over 160 countries, ISO is recognized worldwide and today it is considered inevitable for pharma companies.

In this way, ISO for pharma is a particular area of ISO standards that only deals with pharmaceutical industry. It represents compulsory recommendations for the quality control of pharmaceutical equipment, manufacturing methods, research and development, and associated aspects to ensure safety and hygiene. Hence, a reputable company must always meet these requirements through compliance.

2.What Are The Benefits Of ISO For Pharma?

ISO for pharma carry substantial benefits due to its comprehensive principles that cover every aspect related to public health, drugs, and related equipment. So, in below explanation you will know how positive effects the compliance to ISO for pharma can have on your business at large:

Ensure Safety

The prime objective of ISO for pharma is to ensure safety. Now, it is associated with patients safety as well as the environmental safety because the regulations advocate for using quality material in the construction of pharmaceutical equipment which ultimately reduce the chances of contamination. Similarly, it obliges manufacturers to follow environmental sustainability requirements.

Enhance Efficiency

Precise tablet friability testing- Picture Courtesy: pharmaceutical-networking.com

Running a pharma industry is not a game rather you need to be very serious and attentive at the same time. Thus, ISO for pharma streamline successful practices which are really helpful in reducing time waste. Consequently, by adopting these processes you become able to uplift your production at the very initial stage and skip experiencing any failure.

Improve Quality Control

Quality control icon- Picture Courtesy: devteam.space

Compromise on quality control of pharmaceutical products is nonnegotiable. That's why, ISO for pharma provide basis for each step from initial research to thorough testing and final development of materials. Provision of such tiny instructions can ultimately result in the production of top quality goods which can better add value to patients lives.

Build Global Credibility

Complying to international standards like ISO is now a prerequisite for international trade, reputation, and recognition. Similar is the case with ISO for pharma which helps you uplift the value of your goods and build Global credibility in the competitive market.

Customer Satisfaction

Patient picking capsule

The ultimate goal of every entrepreneur is to have higher demand for produced goods. That becomes pretty easy when you have certification of ISO for pharma as it helps in satisfying customers which is all what you need.

3.Why ISO For Pharma Is Important In Pharmaceutical Industry?

Medicines spilling from bottle- Picture Courtesy: thalassaemia.org

ISO for pharma is considered a compulsory standard in pharmaceutical field because it is the most comprehensive quality standard that deals with every aspect of pharmaceutical manufacturing. Be it drugs production, testing, distribution or the designing of sophisticated machines, ISO for pharma touches every area.

Similarly, it deals with quality management systems, environmental management, and risk assessment etc. This dynamic approach has raised its significance and now pharma companies are bound to follow these regulations. It is crucial for illustrating the company's adherence to safety, quality, and efficacy of products and at the same time signify their excellence.

4.What Are The ISO Requirements For Pharmaceutical Industry?

Generally, ISO requirements for pharmaceutical industry aims at enhancing the quality control stages for the improvement of patient health safety and efficiency of manufacturing. In this way, few such requirements of ISO on part of pharmaceutical industry are as follows:

Capsule testing in pharmaceutical laboratory- Picture Courtesy: emmainternational.com

Quality Management

One of the primary requirement of ISO for pharmaceutical industry is quality management. It represents the regulations that directly deals with the quality of machines and drugs which are to be produced. Thus, it sets forth the construction material for equipment and material for drug manufacturing and packaging.

Testing

Testing is another significant requirement of the ISO which must be carried out in pharmaceutical industry. It is because laboratory testing validates the authenticity, effectiveness, and shelf life of drugs. In addition, transparency testing, tablet friability testing, and dissolution testing are some of the examples in this respect.

Production Methods

ISO also provide a framework and methods which are supposed to be practiced in pharma sector as obligatory measures. This is of paramount importance as it helps the industries to adopt new techniques for production with increase in technology.

Environmental Safety

ISO also guides pharmaceutical industry on using environmental friendly means to reduce waste and minimizing ecological impact. Ultimately, it leads to environmental sustainability.

5.What Do You Do To Apply For ISO Certification For The Pharmaceutical Industry?

ISO application process illustration- Picture Courtesy: isoindia.org

In order to apply for ISO certification for the pharmaceutical industry, you need to start with multi-step process that simply include your understanding of the relevant standard. Once you have finalized the intended standard, it is time to adopt these regulations practically in your business.

Now, select a recognized and credible ISO body and file an application that must include all the necessary aspects which you need such as liability issues, access rights, and confidentiality. Thus, your application is ready to be sent to the concerned body for reviewing and accrediting you with an ISO certificate.

6.Enlist The Major Standards Of ISO For Pharma?

There are several major standards of ISO which are applicable to pharmaceutical sector. These are as follows:

ISO 9001 Standard

ISO 9001 Certification- Picture Courtesy: registrationarena.com

ISO 9001:2015 is considered the most eminent standard of ISO which deals with the quality management systems of any industry. Thus, it is important for pharma in a way that the concerned companies must adhere the quality, safety, and efficiency requirements as well as processes for producing goods. So, that customer expectations can be better fulfilled by supplying quality material.

ISO 14001 Standard

ISO 14001 standard is yet another significant standard that represents concerns for environment. In this way, a pharma company is bound to conduct its practices while respecting the manufacturing compatibility with environmental laws. Similarly, it helps in reducing the negative impact of pharmaceutical companies on surroundings.

ISO 45001 Standard

ISO 45001 Certification- Picture Courtesy: registrationarena.com

It represents occupational health and safety management system which is directly linked to the workforce in pharmaceutical industry. Thus it helps in ensuring the safety life of workers to make sure they perform their functions without any risk.

ISO 50001 Standard

ISO 50001 Certification- Picture Courtesy: registrationarena.com

ISO 50001 standard is another significant standard that is associated with energy management systems demonstrating the practical way for improving use of energy in pharmaceutical companies. With the help of this certification, manufacturers can carbon footprint and wastage is reduced which paves way for cost-effectiveness and efficiency.

ISO 27701 Standard

ISO 27701 is a standard for privacy information management system. It provides a framework for safeguarding the privacy and data of organization. Being a globally valued sector, pharmaceutical company should follow its principles for the procedures and handling of personal data.

ISO 22000 Standard

ISO 22000 Certification- Picture Courtesy: registrationarena.com

This standard is for food safety and management systems. As pharma industry produces edible drugs and other supplements in form of syrups and medicated milk powder and protein powder etc., complying to this standard helps in enhancing its worth. Moreover, customers also have trust in ISO 22000 certified products as they certify the safety of products.

ISO 17025 Standard

It is crucial for drug development and and quality control which are the key factors in pharmaceutical industry. Thus, it focuses on the general requirements for competence of laboratory testing and calibration system.

7.How Do You Do To Become ISO Certificated For The pharmaceutical Industry?

The process for obtaining an ISO certificate for pharma is pretty easy. You just need to follow few steps and making sure requirements of each step are fulfilled properly. These include:

Firstly, you need to determine the type of standard which you want and properly understand all the requirements under it.
Secondly, you need to implement the regulations, that comes under the desired ISO certificate, in your industry.
Thirdly, you are supposed to document the principles which you have applied in your business. For this, you may hire a legal consultant.
Fourthly, the internal audit team will assess the compliance to regulations in your field.
Fifthly, In case of any gaps in adherence to the ISO standard principles, you need provide a strategy in application for how would you fill the gap.
Finally, an external audit team will review your application and after analyzing the current compliance to regulations and future plans for following, you will be awarded the ISO certificate.

8.How Long Is A Certificate Of ISO For Pharma Valid For?

Validity icon- Picture Courtesy: Shutterstock

This question carry great significance for the reason that many pharmaceutical manufacturers often think that they just need ISO for pharma certificate once in a lifetime. However, that's not the case. In fact, it is obligatory for pharmaceutical companies to keep updating their methods, processes, and training staff with respect to changes in demand for safety.

Therefore, the ideal time period for the validity of ISO for pharma certificate is 3 years. After the completion of three years, you need to renew the certification by booking a recertification assessment. In addition to it, a surveillance is conducted annually to check the application of standard in company.

9.What Is The Future Of ISO For Pharma?

Human finger pressing future start button- Picture Courtesy: emmersonwills.com

ISO for pharma is playing vital role in promoting safe and sound processing of drugs from their production till distribution across the globe. This element has now made it quite easy to approach the market in countries where national regulations are not stringent.

In this way, the future of ISO for pharma seems to be more powerful and increasing especially in areas like digitization and data security as the technology is rapidly growing in healthcare industry. Thus, ISO standards like 27001 are getting fame and much expectations are associated with these standards for granting the safety to pharmaceutical companies.

10.What Are The Challenges While Maintaining ISO For Pharma?

Challenge crossing icon- Picture Courtesy: Freepik

While maintaining ISO for pharma, the pharmaceutical manufacturers may face certain challenges during the process. These hurdles are often related to the upgradation of system such as staff training, improvement in existing production methods, and advancing the testing for quality control.

All these requirements need additional resources, time, and energies which ultimately become burden on companies especially those working on small scale. Thus, the most challenging task is the adaptation to changes in standards. However, despite these difficulties, the benefits of ISO for pharma certification are far more valuable.

Conclusion

To put in a nutshell, ISO For Pharma is an obligatory standard for all the pharmaceutical and drug manufacturing companies regardless of what their production level is. The reason is long terms advantages and most importantly public health safety which should be the first priority of every industry. Since, the standard is inevitable to comply, its classification must be understood thoroughly which are explained above. Besides this, it is also very important to keep updating the processes for improvement. So, if you found this article helpful and want to have further information about it, then we are here to help!

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Installation Qualification Checklist

Pharmaceutical Standard

Installation Qualification Checklist

Do you know how important is it to verify all the prerequisites for successful installment of the desired equipment? If not! You should be concerned about it as mere buying an ideal equipment is no justification for its sound working unless and until you have not fulfilled the recommended steps by manufacturer. In this way, Installation Qualification Checklist is greatly helpful that can simply provide you all the necessary qualifications to look for.

This piece of writing will enable you to understand what basically installation qualification checklist is, why is it important for you, and most importantly what it holds. It will also assist you to create a checklist that cover every aspect for successful installment of the equipment including suitable conditions like area, temperature, environment, and utilities etc. So, make sure to give it a thorough read and make best use of your machine!

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1.What Is An Installation Qualification Checklist?

Checklist sample- Picture Courtesy: pharmaguideline.co.uk

Installation qualification checklist refers to a written document that encases all the necessary requirements regarding equipment installation. It verifies that each step for installation of equipment is undertaken properly. Similarly, it include the information which is a collection of both manufacturers recommendations and buyer demands.

Installation qualification checklist is one of the important steps to be taken for successful installment of machines. In addition, it is helpful in identifying the issues or discrepancies during installation qualification and taking timely measures for correction.

2.Why Installation Qualification Checklist Is Important In Pharmaceutical Industry?

Installation Qualification Checklist checking- Picture Courtesy: zamann-pharma.com

Pharmaceutical industry is said to be the most strict field where record of minor information is of paramount importance. This is one of the major reasons why all necessary measures from equipment manufacturing till its quality control checking and execution are performed responsibly.

In this way, an installation qualification checklist play pivotal role for documenting all the prerequisites for sound installation of equipment like tablet compression, encapsulation machine, and ampoule filling line etc.

As all of the pharmaceutical machines need proper environment, area, and adjustment as per fixed design requirements, an installation qualification checklist is a key component to verify their availability.

3.What Contents Are Covered Under Installation Qualification Checklist?

Generally, an installation qualification checklist cover all the details from equipment selection till its deployment and installation. However, it can be better understand by classifying the included information under following headings:

Person identifying equipment- Picture Courtesy: spiraxsarco.com

Documenting Firmware Versions and Serial Numbers

This involves the documentation of information about the firmware versions, serial numbers, and other necessary data about particular equipment. Similarly, completing this step may help in the identification of machine.

Check Software Installation

Verify for the desired software installation in the instrument. Check if the software is updated to latest technology and is functional for carrying out assigned tasks of controlling and regulating machine.

Document Any Computer-Controlled Instrument

As most of the machines are automatically operated by integration of computer system. This step of installation qualification checklist is helpful in documenting any computer-controlled instruments.

Examining Instruments and Components

It signifies the examination of all the instruments and components for their condition like damaged or undamaged. Doing so help in getting prior knowledge and take note of the associated parts.

Gathering All Manuals and Certifications

Gather all the manuals, assurance certifications, and operation guides in order to confirm the validity of installation qualification at each step and making sure you have them on hand.

Perform Operational Verification Test

It records the operational verification test in order to validate the working of equipment in right way. Similarly, each aspect of test is noted and verified by the operator.

Properly Unpacking of Instruments

Properly unpack every part of the particular equipment and examine it for the possibility of wear and tear. Conduct cross-checking to make sure you are proceeding in right way.

Calibration

Conduct the right calibration of every component and system of the machine. Make sure the adjustment done is fully correct and also provide further details about the calibration such as the methods being used.

Drawing List and Documentation

Carry out the documentation of all the things on part of supplier such as the availability of spare parts list, manuals and troubleshooting guide etc.

Ensuring Correct Utility Supply

Inspect the required utility requirements including electricity, voltage, water, compressed air as per the design specifications of instrument. Among other steps, this is considered important for execution of specific equipment.

Environmental and Operating Conditions

It verifies the environmental and operating conditions of the location where instrument is placed. It includes examining the temperature level, humidity, and air pressure etc.

Installing Ancillary Instruments

Install ancillary instruments to the main machine such as wires, cables, adapters, brackets, sensors, seals, and valves etc. These components are significant to aid the machine in working, thus, they should be aligned and fitted properly.

Preventive Maintenance

Check the preventive maintenance of equipment for taking advance measures to counter damage during operation. For this purpose, supply of maintenance guide is very useful.

4.Where Can Installation Qualification Checklist Be Used?

An installation qualification checklist is required for all kinds of equipment which are used in different industries. Some of these are as follows:

Pharmaceutical Industry

Operator setting machine in pharmaceutical industry- Picture Courtesy: technophar.com

Pharmaceutical industry is highly dependent upon the use of sophisticated machines for all kinds of manufacturing such as liquid processing, tablets making, and preparing emulsion etc. Similarly, these machines are designed according to fixed standards and their installation is also subject to specific way for which installation qualification checklist provide the information.

Food Industry

Food industry- Picture Courtesy: Shutterstock

Food industry is another large scale production area where the production and packaging of goods is a routine task. So, if a company want to purchase new machine, it is necessary that the equipment should be installed keeping in view the design specifications which are best known by supplier. Hence, installation qualification checklist is of paramount importance.

Cosmetic Industry

Various cosmetics- Picture Courtesy: harmonicfinance.com

Products like lotion, shampoo, face powder, lipstick, and hair dyes are commonly known as cosmetics. Now, these items are prepared from various raw materials and packed into beautiful packages. The point here is that machines are inevitably used in their manufacturing. Thus, installation comes along every equipment so as installation qualification checklist.

Chemical Industry

Chemicals in beaker & tubes- Picture Courtesy: gtai.de

Similar to pharmaceutical industry, chemical industry is also a very sensitive field where information of each aspect is recorded. In such a case, how is it possible to deny the value of installation qualification checklist that provide tiny information about temperature, humidity, and air etc., for equipment.

Engineering Industry

Precision engineering industry- Picture Courtesy: sac-accreditation.gov.sg

Large scale industries like automobile or engineering often require heavy-duty machinery which should be installed keeping in view range of factors. These factors can be better understand and implemented through an installation qualification checklist.

5.What Is An Installation Qualification Example?

Installation Qualification checking by expert

Installation qualification simply refers to the detailed steps you need to carry out when installing any equipment be it physical or digital. So, let's see how it goes!

Specify the location for equipment installation and check its suitability in terms of space, and outlets, or drains.
Keep record of computer related components.
Make sure to collect all the necessary guides, manuals, and certifications in advance.
Unwrap and adequately cross-check the tools while taking care of the guidelines for doing so.
Examine the various parts and instruments for damage.
Check all the electrical connections including power supply and ensure their corrections.
Install the necessary instruments like ancillary parts.
Document all the relevant information about equipment including firmware versions, serial numbers, and other data.
Evaluate the surroundings for equipment operation like environmental conditions.
Verify software installation and functionality.
Conduct proper calibration and record the related data including dates and techniques used.
Perform verification after attachment of additional units like ancillary parts.

6.Differentiate Between Installation Qualification, Operation Qualification And Performance Qualification?

Icons for equipment qualification stages- Picture Courtesy: madgetech.com

From purchasing a machine till its successful operation, your machine should undergo certain necessary qualifications. These include installation qualification, operation qualification, and performance qualification.

Installation Qualification

Installation qualification ensures that a particular equipment is installed properly with all the mandatory parts. It verifies the area of installation, respective environmental conditions, and utility requirements etc.

Operation Qualification

While as, operation qualification deals with the functionality of machine. Therefore, it checks the working of equipment and draw conclusions on this basis.

Performance Qualification

Performance qualification, as the name indicates, is a validation that provides documentation to the final performance results of specific equipment under given condition. This test is considered the ultimate step for instrument installation after which the responsibility of manufacturer is completed.

Conclusion

This piece of writing not only emphasis the importance of manufacturers recommendations for particular device but also encase your demands which you have placed before purchase. Thus, we hope this Installation Qualification Checklist has helped you to know the important components of it that can assist you in creating comprehensive checklist. Besides, if you want to know further information about the quality documentation of pharmaceutical equipment, you can simply visit our website or leave a message. We will contact you ASAP!

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API Raw Material: The Complete FAQ Guide In 2024

Pharmaceutical Standard

API Raw Material: The Complete FAQ Guide In 2024

Are you scrolling down to get the basic information about API raw material? Probably yes! You might be a keen learner or a manufacturer in pharmaceutical industry intending to fullfil your production needs by incorporating the most essential material which is API Raw Material.

So, we have come up with this FAQ guide which is going to show you everything about API raw material. From its definition till its sources, importance in pharmaceutical industry and the required quality standards, everything will be covered. So, just start reading it and get all what you need!

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1.What Is Meant By API?

API with capsules- Picture Courtesy: iStock

In pharmacy, API is a short term for Active Pharmaceutical Ingredient which refers to the active part of any drug. APIs are of various type, however, they are obtained from the API raw material.

As drug consists of active ingredients and excipients the former work as the main agent for relieving pain or showing desired therapeutic effect. In this way, we may say that API is the vital part of medicines wether tablets, pills, capsules, syrups, or ointments to produce intended health effects.

2.Define API Raw Material?

API raw material with pills & capsules- Picture Courtesy: vereskpolpharmed.com

API raw material is the unprocessed form of active pharmaceutical ingredients. It simply means that they are neither thoroughly processed nor exposed to heat, air, or water therefore available in original form. Such material is obtained from plants, herbs, and fruits etc.

These API raw material is inevitable for making active pharmaceutical ingredients in different kinds of drugs. The quality, strength, and purity of API raw material greatly affect the finished drug product. Hence, it must be handled properly to avoid environmental effects and enhance the essence.

3.What Is The Role Of API Raw Material In Pharmaceutical Industry?

API raw material with tablets- Picture Courtesy: iStock

API raw material is considered paramount in pharmaceutical industry that revolves around the production and processing of various drugs on large scale. There are few such prominent reasons that demonstrate how crucial is the use of API raw material. These are as follows:

Firstly, all kinds of medications whether solid dosage like tablets and capsules or liquid dosage like suspension and emulsions are made by adding active pharmaceutical ingredients which are derived from API raw material.

Secondly, quality control is a major step to be carried out in this sector. That's why, manufacturers want to gather raw material, so, they can process it keeping in view the standards and regulations for retaining drug quality.

Lastly, pharmaceuticals manufacturing is an extensive field thereby requiring bulk API raw material which is both reliable and cost-effective.

4.How Does The Quality Of API Raw Material Influence Pharmaceutical Manufacturing?

Capsules with powder- Picture Courtesy: iStock

API raw material is the building block for pharmaceutical drugs which means the final product is dependent upon the quality of its components. Similarly, if the quality of these raw material is poor it will ultimately affect the quality of produced drug in negative way. The result will be adulteration, ineffectiveness, and risk of contamination in the finished medication.

Contrary to that, using good quality API raw material can have potential positive effects on drug. It can enhance the efficacy, stability, and shelf life of medicines. Hence, the patient will feel more safe to consume the dosage, which leads to customer trust building and help in global reach for your business.

5.What Are The Sources Of API Raw Material?

There are various sources of API raw material. Almost all these sources are natural, however, in some cases raw material is synthesized through chemical processes or in laboratories. Some of the notable sources include:

Plant Sources

Plant sources for drugs- Picture Courtesy: bankofafrica.biz

Plants are said to be the most important and convenient source of API raw material across the globe. Active pharmaceutical ingredients are derived from plants through different processes like extraction, drying, and crushing etc. The common examples of plant sources for API raw material include leaves, seeds, roots, herbs, and fruits etc.

Animal Sources

Different animals in forest- Picture Courtesy: onegreenplanet.org

You may wonder how animals can be the source for generating API raw material but actually it is. In fact, since history most of the drugs made for acute diseases often have their origin from animal sources. Today, we can also see medical practitioners using insects, snakes, animal parts and their secretions for drugs manufacturing. Thus, they are essential source of active pharmaceutical ingredients.

Microorganism Sources

Microorganisms in water- Picture Courtesy: ecosoft.com

In addition to plants and animal sources, the use of microorganisms for deriving API raw material is also prevalent in medical industry. These microorganisms are essential to produce antifungal properties against microbial growth. Hence, it is another significant source to be used for drugs like antibiotics.

6.Classify API Raw Material On The Basis Of Therapeutic Effect?

Drugs testing- Picture Courtesy: mankindpharma.com

Well, API raw material market is such an extensive that you are bound to understand its classification or it will definitely make you puzzle. It is pretty simple. The purpose of this classification is to categorize API raw material, so, one can get the basic idea about each class, their significance, and what could be their potential effects. So, let's begin!

No	Category	Description
1	Cardiovascular APIs	Cardiovascular APIs give high quality ingredients which are beneficial in treating heart related problems like hypertension, angina, and heart failure. These are helpful to advance cardiovascular therapies.
2	Central Nervous System APIs	Such APIs are utilized for curing disorders related to brain, spinal cord, and nerves. Similarly, the drug made by using Central nervous system APIs is effective for treatment.
3	Respiratory APIs	As the title illustrates, respiratory APIs are particularly used to make drugs for alleviating respiratory problems such as asthma, tuberculosis, lung cancer, and cystic fibrosis etc.
4	Dermatology APIs	Dermatology APIs are specifically utilized to treat skin related issues like acne, rashes, and fungal infection. Hence, topical creams, ointments, and gels etc., are made by using these APIs
5	Anti infective APIs	Anti infective APIs are the vital category of API raw material which is widely used in making drugs for ending various infectious diseases. Thus, you may find it in treatment for urinary tract infection, kidney or other parts of body.
6	Immunology APIs	Immune system works as an army against bacteria in our bodies. Thus, immunology APIs are used to supplement and strengthen its growth against diseases, fatigue, and immunodeficiency disorders.
7	Hormonal APIs	Hormonal APIs is another significant class which is made part of the pharmaceuticals that helps in restoring hormonal balance and eradicate certain endocrine illnesses.
8	Analgesic APIs	Analgesic APIs refer to active pharmaceutical ingredients which are used to relieve pain of different types. It includes both non-opioid and opioid analgesics.
9	Oncology APIs	Oncology APIs are essential pharmaceutical ingredients which are be used for treating various types of cancer. These are active substances which are crucial to kill cancer cells and obstruct its growth in body.
10	Gastrointestinal APIs	Gastrointestinal APIs are utilized in making drugs for curing related diseases including acid-related disorder, inflammatory bowel diseases, and gastrointestinal motility problem etc.
11	Ophthalmic APIs	Such ingredients are necessary for treating eye health related issues. They are used in making drugs to cure cataracts, eye infections, glaucoma, and near-sighted corrective surgery etc.

7.Differentiate Between API Raw Material And Excipients Raw Material?

Every medication form is composed of two components which are called API raw material and excipients raw material. These ingredients are considered as two sides of the same coin. However, both different from one another in the core of their aspects. That's why, we have highlighted differences between them for your understanding:

No	Aspects	API Raw Material	Excipients Raw Material
1	Definition	API raw material is the active part of drug which is responsible for treating desired disease.	Excipient raw material refers to the inactive ingredients of a drug for the safe and effective delivery of active ingredients.
2	Function	The function of API raw material is to show desired therapeutic effect.	On the other hand, its purpose is to make the drug stable.
3	Number of raw material	Usually, single API raw material is used for making specific drug.	In contrast, multiple excipients raw materials are used for pharmaceutical making such as lubricants, stabilizers, diluents, and colorants.
4	Use	Its use is compulsory for in every drug.	While as, in some cases excipients raw material may not be inevitable for drug delivery as like in case of herbal powder or homeopathic remedies.
5	Picture	Active pharmaceutical ingredient with capsule- Picture Courtesy: istockphoto.com	Various excipients- Picture Courtesy: pharmadigests.com

8.What Are The Uses Of API Raw Material?

API raw material are used in every sector which is engaged in manufacturing any kind of drug. Some of the prominent applications of API raw material are as follows:

Pharmaceutical Industry

Solid dosage form- Picture Courtesy: actylis.com

Pharmaceutical industry is one of the top beneficiary of API raw material for manufacturing of drugs like tablets, capsules, syrups, and emulsions etc. The sector uses bulk of API raw material in order to treat diseases while maintaining their quality and essence.

Nutraceutical Industry

Nutraceutical medication presentation idea- Picture Courtesy: iStock

Similar to pharmaceuticals, nutraceuticals also require API raw material for making pills and protein powder etc. As most of the drugs under this industry is made for enhancing the intake of vitamins, minerals, and nutrients, API like immunology APIs are popularly utilized.

Herbal Industry

Herbal powder capsules- Picture Courtesy: iStock

Since ancient times, herbal treatment is commonly practiced around the globe for treating various disorders. Interesting thing is that today we also found the significance of herbal byproducts. This is the uplifting of drugs due to innovative technology. Thus, API raw material can be better used in herbal industry for drug manufacturing. The common examples include ginkgo biloba and ginseng etc

Veterinary Industry

Veterinary doctor checking dog heartbeat- Picture Courtesy: petprofessional.com

In addition to humans, animals are also in need of proper treatment when get I'll or affected by any disease. In this way, now multiple forms of drugs can be seen being used for animals. These drugs are made in veterinary industry with the help of API raw material.

Dermatology Industry

Beauty capsules- Picture Courtesy: iStock

Skin treatment for enhancing external beauty, removing acne, dark circles, and keratin treatment for healthy hair is prevalent in today's era. All these tactics somehow involve the use of therapeutic agents which are made by using API raw material. Thus, we may say that dermatology and cosmetic industry do use these active ingredients.

9.What Are The Quality Standards For API Raw Material?

FDA quality certification for drugs- Picture Courtesy: investopedia.com

While API raw material is necessary for manufacturing drugs, it is subjected to stringent regulatory requirements. Adherence to the established rules means the concerned API raw material is produced in a safe environment.

It is because information about each step including its properties, how it is synthesized and how its quality is maintained throughout manufacturing process is of key importance. Thus, several quality standards are there to check the API raw material quality which include the USA Food and Drugs Administration (FDA), European Medicines Agency (EMA), and International Organization for Standardization (ISO).

10.Factors To Consider When Selecting API Raw Material For Pharmaceutical Manufacturing?

Whenever you intend to purchase API raw material for pharmaceutical manufacturing on industrial level, make sure to consider some of the important factors. These include:

Quality

Quality

Pharmacist examining quality of tablets- Picture Courtesy: Shutterstock

Don't forget to check the quality of API raw material you want to buy. Because poor quality can result in the degradation of your final product. Thus, choose for good quality raw material and must check the quality compliance.

Purity

Purity of the API raw material is also very important to examine because polluted or uncleaned material can cause great delays in cleaning and it may contaminate your drugs.

Authenticity

Pharmacist checking capsule ingredients- Picture Courtesy: iStock

What is the origin of API raw material? Knowing this can help you trace how old are the desired material so you will be able to use them accordingly in your manufacturing.

Cost-effectiveness

You will find many suppliers of API raw material in market but you should look into their prices thoroughly. It is because most of the time, there is a big difference in price but not in quality. So, do check its cost-effectiveness.

Conclusion

To wrap up this guide about API raw material, we are glad to have communicated necessary information on much needed topic. The importance of ingredients in drug manufacturing cannot be denied especially in pharmaceutical industry. However, it brings along with it certain responsibilities regarding quality and sources. So, we hope you have got the desired information which will definitely help you in your business. If you are eager to learn more or want to purchase machines for drug manufacturing Allpack is there to show you latest equipment. You can simply contact us through our website!

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ISO VS GMP

Pharmaceutical Standard

ISO VS GMP

Are you involved in the manufacturing sector? Do you want to produce quality goods? Do your industrial regulations include compliance with quality assurance standards? Are you confused about the differences between ISO and GMP? Do you have questions regarding the scope and objectives of ISO and GMP?

The answers to the above-mentioned questions and more will be detailed in this enlightening blog: “ISO VS GMP”. ISO and GMP are similar in various aspects, such as maintaining records, training of operators, calibration of equipment, and product quality tests. Here we will focus on the differences between ISO and GMP so that you can understand the requirements of these regulations and implement them in your business. Let’s start reading.

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1.What is Meant by ISO?

ISO

ISO stands for International Organization for Standardization and is an international body formed from national standard agencies. Its purpose is to create and publish a variety of proprietary, industrial, and commercial protocols.

ISO was created in 1947 in London, United Kingdom. It provides a regulatory framework for running an organization and audits its activity. It is a globally accepted standardized quality management protocol valid for every type of production. It has been reported on ISO website that approximately 1.2 million organizations in 170 world countries have been ISO certified.

It focuses on different facets of seamlessly establishing and managing businesses and is committed to continuously improving quality across every procedure and level of organization. It deals with the requirements of managing and fulfilling customer demands.

2.What is Meant by GMP?

GMP- Picture Courtesy: Angstrom Technology

GMP stands for Good Manufacturing Practices. Sometimes, it is also called cGMP or current Good Manufacturing Practice. GMP regulations uphold a special place in fulfilling the quality assurance protocols and developing quality-compliant products.

It encompasses every facet of the manufacturing process to protect against any catastrophic hazards that degrade the product quality, safety, and potency. It guarantees that products are optimized for their expected use and adhere to marketing or clinical trial regulations.

In 1941, after substandard and contaminated sulfathiazole tablets adversely affected about 300 people, the Food and Drug Administration (FDA) revised manufacturing protocols significantly, leading to the establishment of GMP. These regulations were first finalized in the 1960s and the FDA published its GMP standards in 1963 to prevent contamination of pharmaceuticals and drug formulation errors and ascertain product reliability.

3.What are the Differences between ISO and GMP?

Both ISO and GMP certifications are crucial to quality assessment approaches and by adhering to these regulations, manufacturers and developers can attain fineness in product formulation and provision of services in far and wide productions. They are vastly different from each other, serve immensely diverse objects, and are applicable in dissimilar settings. Let’s look into detail of key differences between ISO and GMP one by one:

Differences between ISO and GMP

Purpose

Purpose

Purpose- Picture Courtesy: Meet Recruitment

The main purpose of ISO regulations is to increase operation performance quality, effectiveness, and, consumer trust in diverse industries. Its primary job is to make a structural framework and process-centric methodology to establish quality assurance.

GMP is specially devised to ensure every regulated industry- producing health-related and beauty-related products- conforms to quality standards in manufacturing, processing, packing, handling, and storage. It is product-oriented and deals with the shortcomings of products that adversely affect the well-being of humans.

Focus

Focus

Focus- Picture Courtesy: Alcimed

ISO and GMP differ significantly in their focus. ISO is related to the organization's general management and is strongly focused on customer opinions- both external and internal. It includes standards for satisfying customer demands, fulfilling their expectations, and gaining customer trust. It is more committed to enhancing the management of the business. It usually mandates organizations to devise quality policies and goals.

It is usually focused on running the business in the right way, although one of its goals is to manufacture the right quality product, it has other objectives, such as establishing responsibilities of top management for quality assurance.

ISO advises companies to inspect, revise, and boost their quality system for leading perfection in other non-production areas.

Alternatively, GMP is dedicated to guaranteeing the safety, security, durability, quality, traceability, recognition, and sterility of consumable goods. It is responsible for protecting the health and safety of consumers, especially patients from adverse reactions and other possible harms. By GMP guidelines, organizations are obligated to document their every manufacturing step.

GMP is more deeply concerned with product quality and gives more emphasis to standardized manufacturing practices.

Industrial Uses

Industrial Uses- Picture Courtesy: Moravek

ISO and GMP are widely diverse in their industrial applications. ISO is valid for every organization, whether production, healthcare, laboratories, construction, trade, or others, and is not unique to any facility or production line.

On the contrary, GMP protocols are exclusively implemented in industries- regulated by drug and food regulatory agencies, for instance, the medicinal, biotechnology, nutraceutical, veterinary, medical instruments, food, beverage, and, beauty industries.

Regulatory Requirement (Voluntary or Mandatory)

Regulatory Requirement- Picture Courtesy: Single Use Support

Acquiring the ISO certification is completely voluntary and organizations usually get a competitive edge over their competitors and customer trustworthiness by adhering to this certification.

It is noteworthy that there are no legal ramifications of not obtaining ISO certification. Still, for successfully operating an organization this certification is a must. The firms are free to adopt ISO regulations to show their clients that they are committed to quality.

However, laws and guidelines are an absolute must for pharmaceutical and food companies. The governing bodies, especially FDA and EMA dictate and review compliance with the GMP standards. GMP standards are enforced by law and are a must for production approval licenses. Companies must adhere to GMP to legitimately produce, market, and sell their consumable goods.

Certification vs Auditing

Certification vs Auditing- Picture Courtesy: PharmOut

Organizations interested in implementing ISO certification must undergo auditing through third-party bodies that are qualified to inspect and audit different patron businesses. ISO-accredited certification agencies measure performance compliance with ISO regulations. Moreover, these organizations are audited every year and are awarded ISO certification for three years between renewals.

FDA or EMA conducts annual inspections and reviews to ascertain GMP conformity. Moreover, they can reject or withdraw manufacturing permissions if guidelines are not implemented properly. The supervising bodies, found in almost every country across the globe, examine GMP adherence by regularly visiting facilities.

There are some harsh punishments and monetary penalties if GMP standards are not followed in the book.

Inspection Procedures

Inspection Procedures

FDA inspectors are allowed to review compliance with the newest or current regulations that are approved as required industrial procedures even though they are not specially mentioned in written guidelines. Conversely, ISO inspectors can only assess ISO compliance to the very last version of the ISO standard.

Scope

Scope

Scope- Picture Courtesy: CordenPharma

There are different variants of ISO and its scope is a lot broader than GMP. ISO 9001 usually accentuates quality management and quality assurance. ISO 14001 defines criteria for environmental management systems, while ISO 45001 deals with occupational health and safety management. Conversely, GMP envelops every facet of manufacturing, such as starting material, training, hygiene, facilities, equipment, and documentation.

Requisites

Requisites

ISO needs a management assessment review, quality strategy, quality guidelines, or quality auditing. It also defines a supplier assessment protocol or a procurement process. Opposingly, GMP mandates that buildings, warehouses, facilities, and equipment must adhere to strict regulations for size, cleaning and maintenance ease, sterility maintenance, ventilation, calibration, heating, cooling, electricity, plumbing, water treatment, sewage, and routine hygiene.

Quality Control

Quality Control

ISO does not overtly mandate the formation of a quality control unit, consigned with the power to accept or reject products. Instead, ISO urges businesses and companies to specify the roles and duties in quality management systems. It demands the appointment of management personnel who have the power to implement the standard.

Conversely, GMP specifies the need for the creation of quality control units with complete and absolute clout to accept or reject the product. It also defines the particular structure and responsibility of the quality control unit.

Documentation

Documentation

ISO usually necessitates a documented record of quality management systems, operational practices, and risk management strategies. Since GMP is more concerned with the implementation of quality requirements, it needs more thorough and stringent documentation, centering on batch records, SOPs, and product testing protocols.

4.How are ISO and GMP similar?

ISO and GMP concur on important points related to quality management. They both are designed to ascertain that products and processes fulfill required quality regulations. Some significant similarities between ISO and GMP are discussed below:

Simmilarities between ISO and GMP

Emphasis on Quality

Emphasis on Quality- Picture Courtesy: World Pharma Today

ISO 9001 and GMP are focused on quality. Both entail constant assessment to boost quality outcomes. They ensure the manufacturing of superior-quality goods. Consistent quality and operative fineness are their top priority. Both approaches are developed to prevent the errors in first place.

Record Keeping

Record Keeping

ISO and GMP heavily prioritize detailed and thorough documentation. They dictate the importance of comprehensive record-keeping for auditing, inspection, and, quality management. Correct records in ISO standards are essential for maintaining process consistency and continuous improvement. Whereas, in GMP, documentation plays an integral role in product traceability and is indispensable in quality control and accountability.

Continuous Improvement

Continuous Improvement

Both standards prescribe the need for incessant improvement in manufacturing and servicing Plan-Do-Check-Act (PDCA) cycle is vital to process improvement in ISO standards. It advises organizations to routinely evaluate and boost their processing quality.

On the other hand, continual improvement in the fulfillment of GMP quality requirements occurs through regular assessment, and CAPA (corrective and preventive actions).

Both ISO and GMP monitor unceasing quality enhancement by product testing, supplier auditing, process evaluation, product assessment, self-inspection, and addressing customer complaints.

Training

Training- Picture Courtesy: BiOZEEN

ISO and GMP dictate that employees and operators in facilities must be properly trained and equipped with the necessary skills to perform their duties capably. ISO regulations obligate that the workforce must be rightly qualified for the jobs they perform, which minimizes errors and boosts product quality. Similarly, GMP mandates operators must be trained so that they can learn about hygienic practices, contamination hazards, and their processing duties.

Auditing

Auditing- Picture Courtesy: TPA Group

It is mentioned in both ISO and GMP guidelines that organizations must carry out external and internal inspections to certify compliance with regulations. ISO inspections are performed by accredited organizations, whereas GMP inspections are conducted by regulatory agencies to evaluate safety and quality compliance.

5.What are the Benefits of Implementing ISO and GMP?

Implementing both ISO and GMP comes with numerous benefits, including enhanced quality assurance, regulatory conformity, customer satisfaction, and operational performance. Let’s detail the different advantages of adopting ISO and GMP in businesses:

Improved Quality and Safety

Improved Quality and Safety- Picture Courtesy: Sirocco Consulting

Implementing one or both of these industrial standards will lead to improved manufacturing quality. By complying with these standards, organizations are consistently boosting their operational, packing, and distribution excellence. Moreover, safe, pure, and potent pharmaceutical, medical, and, cosmetic products will be delivered to end-consumers by adhering to the strict specifications of ISO and GMP- related to manufacturing, handling, and, storage.

More Market Access

More Market Access

Adherence to these globally recognized standards means that companies follow best manufacturing practices and reduce manufacturing errors and deviations. This leads to a boost in customer trust and brand popularity. So, brands gain access to far and wide market areas and fulfill global trade requirements.

High Employee Competence

High Employee Competence

ISO and GMP stress the necessity of continuous employee training to promote quality awareness and hygienic practices in organizations. This creates a skilled batch of knowledgeable and committed workforce who always strive to uphold industrial standards, leading to increased workforce engagement and productivity.

Better Supply Chain Management

Better Supply Chain Management

Rigorous supplier assessment protocols by ISO ensure better quality and consistency of the supply chain. GMP mandates stringent quality controls on raw feed, procurement of equipment, and other parts. With both these standards, a strong and trustworthy supply chain is created, promoting optimized product quality, lowering disruptions of the supply chain, and decreasing the rate of ambiguous materials entering production facilities.

Waste Reduction

Waste Reduction

The basis of ISO 14001 lies in minimizing the environmental impact of processes by increasing resource use, decreasing waste, and augmenting energy consumption. Moreover, GMP controls also cut down resource and product wastage by reducing production anomalies, contamination, and, item recall. This implementation of both ISO and GMP results in green, eco-friendly, and cost-effective operations.

Safer Operational Environment

Safer Operational Environment

ISO standard is also related to minimal operational accidents and incidents, in turn improving the safety of the workplace. GMP stresses the importance of sterile, aseptic, and safe procedures to avert contamination and thus protect workers from health adversities. They both assist in establishing safe and compliant operational settings, safeguarding employees as well as the composition of products.

6.How can ISO Complement GMP?

Although ISO and GMP have somewhat diverse focus, employing them together is an intelligent approach. They both complement each other successfully in regulated industries, for instance, pharmaceutical, food, and healthcare.

Risk-Based Strategy

Risk-Based Strategy- Picture Courtesy: Stratex hub

GMP incorporates risk management strategies, for instance, detecting device failure and product flaws. In ISO, a structured approach is utilized to implement risk-based thinking across the whole organization. The latter urges firms and businesses to proactively detect hazards and opportunities in the operating processes, which complements the GMP approach of averting quality errors and deviations.

Customer Focus

Customer Focus- Picture Courtesy: Medium

ISO strongly emphasizes learning and fulfilling customer requirements. Incorporating customer-centric principles into GMP regulations urges companies to take into account regulatory compliance and the needs of end-consumers.

Thus, by associating manufacturing processes with consumers' needs, GMP can concentrate on product quality, strength, and safety that directly fulfill or surpass customer expectations. It can result in the creation of customer-compliant goods that reverberate well with consumers, boosting their trust and loyalty.

Organization Efficiency

Organization Efficiency

The focus on GMP lies on the practical aspect of product engineering, whereas, ISO considers a methodical approach to improve the efficiency of organizations and non-production procedures, for instance, buying, sales, and customer support.

Therefore, by incorporating ISO process improvement with GMP standards a stronger regulatory framework is created, which boosts product quality, manufacturing efficiency, and risk management approaches, and cuts redundancies.

Conclusion

In conclusion, the ISO and GMP are two distinct standards with diverse scope, purpose, focus, regulatory requirements, and, auditing processes. ISO is more process-centric while GMP is more product-centric. However, the end goal of both these regulations is to ensure better and enhanced product quality. The anticipated advantages of effectively integrating these regulations are huge in terms of return on investment. By implementing these standards in harmony, you can achieve superior-quality products, decrease product shortages, reduce validation and documentation, and rapidly deliver more products to market. For more details and queries regarding differences between ISO and GMP, you are encouraged to contact Allpack customer care.

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Performance Qualification VS Operational Qualification

Pharmaceutical Standard

Performance Qualification VS Operational Qualification

In the pharmaceutical and clinical industries, even a slight mistake can lead to serious problems. Therefore, in the pharmaceutical, medical device and clinical industries, they should be strictly regulated. In order to ensure the safety and quality of equipment in production and operation, operational qualification and performance qualification are proposed and strictly stipulated.

Performance Qualification VS Operational Qualification-sourced: csolsinc

What is operational qualification and performance qualification? Why they are important? How to perform and what you need to pat attention? Following this performance qualification vs operational qualification post, you may grab the free guide. Let's go!

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1.What Is Operational Qualification?

What Is Operational Qualification-sourced: tgm

Operational qualification refers to a series of tests on equipment. Its purpose is to determine whether the equipment performance meets the user's requirements and specifications within the operating range specified by the manufacturer. This type of testing has specific requirements and specifications.

After testing, the performance of the equipment will be recorded. It includes a detailed review of the equipment startup, operation, maintenance, cleaning and safety procedures of the equipment hardware and software.

2.What Is Performance Qualification?

What Is Performance Qualification-sourced: Pharmaguideline

Performance qualification is the next step after operational qualification. It is the final stage of equipment certification. Performance qualification does not test the components and instruments of the equipment separately.

It generally introduces a third-party expert to ensure the thoroughness and accuracy of the equipment. The purpose of this process is to ensure that the product quality of the equipment is continuously guaranteed during its operating time.

3.Performance Qualification VS Operational Qualification: How To Perform?

Unlike operational qualification, performance qualification does not test individual parts of the equipment.

How To Perform Operational Qualification-sourced: Pharmaceutical Specifications

	Operational Qualification: How To Perform
Perform functional tests	l Perform tests to verify that the equipment's operating functions are within the specified range.
Safety measures check	l Test all safety functions of the equipment, including alarms and fault protection, to ensure that the equipment is in normal working condition.
Validation plan development	l Record the complete equipment test performance and data, and analyze the deviation from the expected parameters.
Report generation	l Compile all data reports into a comprehensive operational qualification report in accordance with specifications and requirements for subsequent retrieval and review.

How To Perform Performance Qualification-sourced: gmpinsiders

	Performance Qualification: How To Perform
Unify performance standards	l Clear and unify the performance standards of the equipment under operating conditions.
Long-term equipment testing	l Run the equipment for a long time to record and evaluate its long-term performance.
Environmental condition testing	l Run the equipment in different environments and conditions to record and evaluate its performance.
Data analysis	l Verify, correct and re-test the different differences shown by the equipment under different environments and conditions.
Report generation	l Compile all data into a detailed performance qualification report for subsequent retrieval and review.

4.Performance Qualification VS Operational Qualification: What Makes Them Successful?

After the operational qualification and performance qualification are performed, you may know whether they are successful through the following standards and indicators. They are:

OQ-sourced: nodeviation

The equipment can operate normally within the operational range;

All operational tests meet the acceptance criteria of the operational qualification protocol;
During the test, the equipment operation has no deviations or unqualified conditions;
During the test, the deviation of the equipment operation will not affect the overall capability or other performance of the equipment;
The equipment can correctly identify and handle faults and errors;
It can connect other integrated equipment without any compatibility issues or interruptions;
Positive operator and user feedback;
The operational qualification test is successfully completed and all standards are met.

PQ-sourced: media

The equipment's products and product processes meet the standards;
The equipment's process capabilities are stable and meet the standards for a long time;
The equipment's system can handle multiple products without lag problems;
The work processes will not affect each other;
The equipment can correctly identify and handle different known materials;
The equipment can operate normally and meet the relevant standards in actual work;
The equipment can automatically identify some potential unqualified conditions during operation, including: overheating, excessive vibration, noise, pressure difference, process medium back-flow, etc.

5.Performance Qualification VS Operational Qualification: Why You Should Perform PQ And OQ?

Why should you obey and perform the operational qualification and performance qualification? In short, this is the FDA's requirement. To expand, its benefits are:

Reasons to Perform Operational Qualification-sourced: polarseal

Reduce risks

Obtaining operational qualification in advance can reduce the risk that the equipment cannot operate normally or as expected, thereby it can reduce the loss of users.

Protect equipment parts

If the equipment does not pass operational qualification, it may face risks such as component damage, software problems, and workflow problems. After operational qualification, these problems can be well eliminated and parts can be protected from damage.

Help manufacturers improve

Only through a series of tests in operational qualification can equipment manufacturers find problems and make corresponding improvements. Therefore, the upper and lower limits of the equipment can be determined and the corresponding operating standards can be made.

Reasons to Perform Performance Qualification-sourced: polarseal

Eliminate potential equipment problems

The hardware and software problems of the equipment may meet the standards, but it is difficult to find other potential problems without operating tests. For example, overheating, excessive vibration, noise, pressure difference, etc.

Ensure equipment performance

Through performance qualification testing, the normal and stable operation of the equipment can be guaranteed, thereby ensuring the performance of the equipment for a long time.

Forming validation documents

If any problems occur during the use of the equipment, the verification documents of performance qualification can be used to eliminate the problems in the operation of the equipment and help users, manufacturers or regulatory agencies to find the cause.

6.Performance Qualification VS Operational Qualification: What Are Their Essential Documentation?

When the equipment has passed the operational qualification and performance qualification, a comprehensive document will be formed. It includes:

OQ Documentation

OQ Documentation-sourced: golighthouse

Operational qualification documentation mainly includes the equipment's objectives, scope, methods, acceptance criteria, requirements, and reports.

Objective: clarify the equipment's objectives, specific operating parameters and functions that need to be tested.

Scope: equipment-related components, systems, hardware, software, and operating procedures;

Methods: equipment operating steps and procedures, related conditions and settings, etc.;

Acceptance criteria: what conditions the equipment needs to meet to pass each test;

Requirements: manufacturer and user specifications, supervision of equipment, etc.;

Report: OQ report mainly records the execution and test results of the equipment, including whether it is faulty, whether there is deviation, etc.

SOP: mainly includes equipment operation, maintenance, calibration, processing, recording deviation and other procedures.

PQ Documentation

PQ Documentation-sourced: golighthouse

Performance qualification documentation mainly includes equipment pre-qualification inspection, program testing, data collection, acceptance criteria, deviation management, document formation, document approval and review.

Pre-qualification inspection: ensure that the equipment has been properly installed and calibrated, and properly maintained;

Procedure testing: ensure that the content and process of the equipment's system procedure testing are fully executed;

Data collection: determine the data collection method and ensure that the data collection tools and systems are operating normally;

Acceptance criteria: clarify that the equipment's acceptance criteria meet industry standards and regulatory requirements;

Deviation management: debug, correct, record and retest equipment with data deviations;

Documentation: ensure that all required documents are complete and correct;

Approval and review: requires review and approval by relevant personnel.

7.Performance Qualification VS Operational Qualification: What Are Their Reports?

Compared with operational qualification documentation, its reports are simpler. It is mainly used to verify whether the equipment system, software or hardware operates as expected.

OQ reports

OQ reports-sourced: biotechserv

List of test items for equipment acceptance criteria;
Documentation for executing equipment test runs;
List of information about equipment test items and sequences;
List of designated equipment test tools;
List of equipment acceptance criteria;

Performance qualification reports are the final documents for the entire equipment. It indicates that the equipment has passed the test and meets all standards.

PQ reports

PQ reports-sourced: dicksondata

Test summary: including an introduction and objectives of the equipment test;

Summary of test content: detailed description of the equipment execution process, including test methods, environmental conditions and test results;

Data analysis: the analysis and improvement of data deviations and qualification process;

Test conclusion: summary of test results;

Test recommendations: recommendations for improvement and adjustment of subsequent equipment;

Approval: signature of test and responsible personnel;

8.Performance Qualification VS Operational Qualification: What Are The FDA Requirements?

FDA attaches great importance to the qualification process and it is part of its regulation. The purpose is to allow drugs and medicines to be manufactured under normal and controlled conditions. Their requirements are:

Comply with good manufacturing practices

Comply with good manufacturing practices-sourced: eriks

FDA requires that devices should follow good manufacturing practices. This includes accurate documentation, precise data collection, and performance testing that meets standards.

Data integrity

Data integrity-sourced: fivevalidation

Whether you perform operational qualification or performance qualification, you need to ensure the accuracy, consistency, authenticity, and reliability of the test data during the test process. If there are any deviations, they need to be marked and explained.

Document compliance

Document compliance-sourced: docsvault

You need to archive the qualification process and related documents to facilitate audits and supervision by subsequent staff.

9.Why Is Performance Qualification And Operational Qualification Critical In The Pharmaceutical Industry?

The operational qualification and performance qualification are critical in the pharmaceutical industry rather than other industries. Reasons are:

Regulations of the U.S. Food and Drug Administration (FDA)

Regulations of the U.S. Food and Drug Administration (FDA)-sourced: thefdagroup

This is a hard requirement of the FDA. The FDA believes that equipment certification is essential for the production and production of drugs. Any manufacturer needs to ensure that their equipment is well designed, easy to clean and maintain, and has the prescribed effectiveness and suitability.

Product quality assurance

Product quality assurance-sourced: sofeast

Only equipment that has passed operational qualification and performance qualification can its quality be guaranteed. And it can help drugs to be produced safely and accurately.

Patient safety assurance

Patient safety assurance-sourced: encrypted

Even the slightest equipment installation error may cause the produced drugs to have fatal consequences for patients. Only by ensuring the production and operation safety of the equipment can the safety of patients be guaranteed.

Help record and track

Help record and track-sourced: integrity-asia

Even if the equipment has passed operational qualification and performance qualification, there is a chance of problems in the later operation. Therefore, the relevant test records can well help users troubleshoot, record and track.

10.What Types Of Tests Are Conducted During Performance Qualification And Operational Qualification?

There are specific tests need to be conducted during the operational qualification and performance qualification.

The main OQ test types are:

The main OQ tests-sourced: media

Functional test: mainly checks whether the equipment operates as expected;

Stress test: evaluates the operating effect of the equipment under extreme conditions;

Calibration check: ensures the accuracy and stability of the equipment;

Repeatability test: takes the average of multiple running results to evaluate the stability of the equipment.

The main PQ test types are:

The main PQ tests-sourced: susupport

Operating range test: evaluates the upper and lower limits of the equipment;

Calibration and verification check: compares and verifies with known standards to ensure accuracy and consistency;

Sample analysis: tests samples produced during the operation of the equipment to check whether their quality meets the standards;

Integration test: connects with other whole-line equipment to ensure the smoothness and stability of the whole line.

11.What Happens If Performance Qualification And Operational Qualification Test Failed?

Operational Qualification and Performance Qualification Failed-sourced: chapter5academy

If the operational qualification and performance qualification tests fail, the reason may be that the test results did not achieve the expected effect, or the data produced a very large deviation. This equipment may need to be adjusted, repaired or re-qualified. The operational qualification and performance qualification can be re-qualified by re-adjusting the equipment.

12.What Are The Best Practices For Writing Performance Qualification And Operational Qualification Protocols?

After passing the operational qualification and performance qualification, you need to write the corresponding qualification protocols. You can follow the practices below to do this.

Practices For Writing Operational Qualification Protocols

Operational Qualification Protocols-sourced: madgetech

Operational Range

Normal environment testing, upper and lower limit environment testing. For example, you can test the device at the highest speed and the lowest speed range. This ensures that the device maintains stable performance during variable production requirements.

Failure Mode Testing

Test the device's ability to detect and handle fault conditions by simulating fault scenarios. This evaluates the reliability of the device's protection measures and management system.

Interoperability Testing

Connect the device to other devices or other complete lines to test the device's interoperability. To ensure seamless connection and online between systems.

Execution Sequence Testing

Have the device operate the test as required and record the execution sequence. This can reflect the use of the device during the production cycle, ensuring a smooth and efficient production workflow.

Load Testing

Load the device under different conditions, including maximum capacity and variable load. This ensures that the quality and reliability of the device can be maintained under load.

Practices For Writing Performance Qualification Protocols

Performance Qualification Protocols-sourced: madgetech

Real-time Monitoring

Use real-time monitoring tools to analyze and summarize the real-time data provided during the operation of the equipment for subsequent adjustments.

Dynamic Adjustment

Combined with the application of process analysis technology, dynamic adjustment of parameters is performed.

Scalable Protocols

Design scalable protocols. Make sure that the protocols you design are scalable. This will facilitate the subsequent test process to expand the production scale.

13.Performance Qualification VS Operational Qualification: What Is An Equipment Qualification Protocol?

Equipment Qualification Protocol-sourced: egnyte

The equipment qualification protocol is a written plan. It describes the qualification process of the equipment. This protocol mainly includes the component evaluation of the equipment, the steps of OQ and PQ qualification, parameter testing, product testing, and the production process and deviation handling.

Step 1

Write and formulate the protocol. A detailed document is prepared by relevant staff or experts. It mainly includes the scripts, methods and steps you need to test. Standardize acceptable test results. Specify relevant parameters and acceptance criteria.

Step 2

Prepare the pre-checklist. Evaluate the system for equipment inspection and testing to ensure product quality and user safety. Establish and divide the corresponding time and responsibilities.

Step 3

Thoroughly understand and inspect the equipment. Understand the intended use and effect of the equipment and recognize the functions of the equipment.

Step 3

Test the equipment according to the requirements and specifications. And collect the necessary documents and data. Handle it according to the design specifications and standard operating procedures.

Step 4

Understand the documents and processes required for certification OQ and PQ. Understand the overall process flow of the equipment.

Step 5

Review the FAT and SAT records that have been carried out. Conduct evaluation and analysis.

Step 6

Thoroughly review current regulatory guidance and warning letters. Develop clear and concise protocols.

Conclusion:

Operational qualification and performance qualification are key processes in the pharmaceutical industry. In addition to enabling equipment to operate continuously and effectively, they also ensure product compliance, high quality, and safety. Through this complete performance qualification vs operational qualification guide, you can also follow such a guide later. If you have more questions, you are welcome to consult ALLPACK now!

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Performance QualificationThe Complete FAQ Guide In 2024

Pharmaceutical Standard

Performance QualificationThe Complete FAQ Guide In 2024

If you are in the process of getting GMP standard, you may know the performance qualification which also called as PQ in many place. It is the qualification which test the processing performance of your industry. You cannot ignore it if you want to make your manufacturing process reliable and efficient.

How much you know about it? Why you need performance qualification? What industry can performance qualification be applied? What is performance qualification testing? Performance qualification isn’t a complex qualification. After the reading of this post, you may become the expert in performance qualification!

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1.What Is Performance Qualification And What Its Aim?

Performance Qualification- Sourced: ciqa

Performance qualification is the kind of qualifying test which tests your equipment to find its process and working problem in expected or actual condition. It can help you find the potential problem in your processing and can prove the right processing result and safe and consistent manufacturing process.

To get your GMP standard, you may give the performance qualification process which shows the standard and qualified equipment working process. It aims to promote the smooth and consistent equipment performance and gets the right results. This qualification can be applied in manufacturing of medical products , instruments and utilities.

2.Why YouNeed Performance Qualification?

Why you need performance qualification? Is it essential for your manufacturing. In a word, one cannot get your GMP standard without your performance qualification. And besides, it also has other benefits which will promote your manufacturing business.

Make standard processing

Make Standard Processing-Sourced:geeklymedia

Performance qualification can prove your manufacturing equipment and process in standard. The standard processing may prove the smooth and efficient manufacturing. You may thus get the high efficient work and have your profits improved.

Prove product quality

Prove product quality-Sourced :corporatevision-news

Performance qualification investigates the manufacturing process. For the unqualified or unreliable tactic, the timely optimizing can avoid the making of the unqualified results. It in some way prove your results’ quality and can force the production line to make products with high quality.

Reduce your business risk

Reduce Your Business Risk-Sourced:integrify

Performance qualification can reduce your business risk as it identifies and corrects problems. The minimizing of problems and deviation reduce your business risk. And the standard performance which align with law, business requirements and user requirements can also help reduce your business disputes.

Better regulation

Better Regulation-Sourced:sloanreview

For any problem in manufacturing or using process, the well recorded performance qualification may give the relative documents as evidence. This helps the efficiency of problem solving as it improves the speed of regulatory authorities and manufacturer to retrace and solve problems.

3.What Industry CanPerformance Qualification Be Applied?

Performance qualification can be applied in many places as it is an essential part of GMP standard. Here are the representative industries which required the performance qualification.

Medical device industry

Medical Device Industry-Sourced:brighton-science

There is a legal requirement of FDA about medical device. There are also clear requirement on machine designing, locating, performing, maintaining and so on. For the medical device industry which updates with high speed, performance qualification is essential as it proves the great performance of machine and takes the reliable and safe processing.

Pharmaceutical industry

Pharmaceutical Industry-Sourced:viracresearch

Performance qualification is very important in pharmaceutical industry. It improves the manufacturing process and tests the feasibility of manufacturing. Performance qualification helps make the welcomed and reasonable medical products.

Food industry

Food Industry-Sourced:amtrustfinancial

In food industry, performance qualification is also inescapable. It proves the actual smooth, safe and efficient manufacturing by testing the food making process. And it also can avoid risk by careful testing of performance. In a word, it assures the food quality and your business profits.

4.Why Performance Qualification Is So Important In Pharmaceutical Industry?

In pharmaceutical industry, performance qualification takes an important position and makes a lot for great pharmaceutical products manufacturing.

Test feasibility

Test Feasibility-Sourced:rmsresults

Performance qualification is an important part to test feasibility. There are various medical dosage and also various medical device type. To get the real suitable one, you should make the strict performance qualification to test the feasibility of your pharmaceutical production line.

Make qualified products

Make Qualified Products-Sourced:oktopost

To make the qualified medical products, you should first of all make sure the pass of performance qualification. The performance qualification acceptance criteria can prove the qualified manufacturing and products making. Besides, the small damage of instruments can also be found and solved for the nice and qualified products making.

Prove the processing efficiency

Prove The Processing Efficiency-Sourced:businessmapping

Performance qualification tests the capability for the consistent operating. It also tests the efficiency of other tactic and operation. In performance qualification, you can find the flaws in processing and improve your efficiency by improving or ameliorating the missing part. The medicine processing efficiency can improved in this way.

5.What IsPerformance Qualification Testing?

To pass the performance qualification, you may first get the performance qualification testing. Here are some of the detailed testing contents.

Operator training

Operator Training-Sourced:nhancetech

There are standard in operating parameter and limits in performance qualification. Thus, you should make the special operator training to standardize operating. You should make clear the operator parameter and limits of your field and then trained your workers to make the reliable operation.

SOP

SOP

SOP-Sourced:ceomastery

SOP is the abbreviation of standard operating procedure. It includes the cleaning, maintaining, operating and other procedure for equipment or processing system. In performance qualification testing, SOP is also an essential part which shows the regulation and standard of equipment processing.

Production material

Production Material-Sourced:happho

Performance qualification testing uses production material, qualified substitute material or simulated products to get reliable results of different operating conditions. It can thus get the appropriate production material and get the results of different operating parameters under different material.

Processing parameter

Processing Parameter-Sourced:corporatefinanceinstitute

Processing parameter is one deciding factor which affects the manufacturing efficiency and products feature. In performance qualification testing, there is also part for the processing parameter investigation and study.

6.What Are The Requirements For Performance Qualification?

It is suggested that performance qualification should be written well with great care and concerns. And here are the requirements for your performance qualification.

Requirements on operation

Requirements On Operation-Sourced:zenbusiness

The requirements on operations make the regulation on manufacturing condition and operating manner. You should make clear testing operation like standard operation parameter, instruments limits and inputting number. You should also make clear the material applied in performance qualification testing.

Requirements on time

Requirements On Time-Sourced:laurabrandenburg

Time is the important parameter for performance qualification. There are requirements on time frame in repeatability, time limits and so on. There should be requirements on time as it in some way affect the operational parameter.

Requirements on test plan

Requirements On Test Plan-Sourced:qaworld

The test plan should make the clear requirement on material, testing machine, calibration manner, validation manner, assessing manner, sampling plan and so on. Besides, you should also make clear the way to deal with unqualified situation and remediation manner for the emergency condition in performance qualification testing.

Requirements on operator

Requirements On Operator-Sourced:flaticon

The operators for performance qualification are varied. You should make clear their qualification and training plan. There are also other relative personnel for different department for you consider for smooth and reliable performance qualification.

7.What Is Performance Qualification Acceptance Criteria?

The qualification acceptance criteria isn’t that difficult or complex. Here is the essential qualification acceptance criteria which may guide your behavior in performance qualification.

Temperature monitoring

Temperature Monitoring-Sourced:zenatix

Temperature monitoring provides the essential evidence about temperature products maintained in processing or transporting. The temperature should be set according to the operation norm in SOP. Temperature should not be neglected as it in some way affects manufacture processing and also the products feature.

Packaging integrity testing

Packaging Integrity Testing-Sourced:purple-diamond

Performance qualification has the visual inspection for packaging. The primary, secondary, tertiary packaging and ancillary components should be inspected with great care. In this part, you should emphasize the integrity of packaging and products. The integrity can be assessed by limiting quality, inspection, sample plan and so on.

Transporting process confirming

Transporting process confirming-Sourced:mykn.kuehne-nagel

Your well made products may get damage in transporting. There are minor, major and critical damage for a product. And the smallest damage may lead the interest damage as it reduce the products integrity. There are functionality testing, product quality attribute testing and container closure integrity testing in performance qualification as testing manner.

8.What Element Should Be Considered In Performance Qualification?

There are several essential elements which you should considered seriously in performance qualification. The violating of these elements may lead the mistakes in performance qualification

Accuracy

Accuracy-Sourced:documentmedia

The results of performance qualification should be precise or the wrong results may affect your later processing. Accuracy is one of the most important element of performance qualification. The precise results is the base for qualified products making and reliable analytical data.

Stability

Stability-Sourced:thebluediamondgallery

You may assure the stability of your performance qualification result. You may also prove the stability of results by investigating instruments or equipment seriously. The assurance of stability in performance qualification makes sure the little deviation or fault in operating.

Repeatability

Repeatability-Sourced:aivaraszvinklysofficial

There are so many factors which may affect your performance results. To get the reliable products results, you should make the repeated testing. The repeated testing can reduce the affect of changing factors happened in regular operating. The repeatability can thus makes the more dependable results.

Regulatory Compliance

Regulatory Compliance-Sourced:essentialdata

Performance qualification makes the strict investigation about the relative law or standard the industry applied. To pass the performance qualification, the equipment and instrument must adhere to the relative GMP, cGMP, SOP and other relative laws or regulations. The violating of regulation may lead fail in performance qualification and damage to your business.

Document compliance

Document Compliance-Sourced:cio

The strict and precise data is one powerful evidence for performance qualification investigation. The careful recording of various data in manufacturing process is thus irreplaceable in performance qualification. You should record as detailed as possible. Besides plan and results, the deviation is also helpful in trace.

9.What Are The Key FeaturesOne Should Consider In Performance Qualification Phrase?

In performance qualification phrase, one should take much emphasis on the key features which affect your qualifying phase when making the performance qualification testing.

Controllable environment

Controllable Environment-Sourced:starrco

For performance qualification, you should make the controllable environment. You may then test the typical operating environment and the worst one. The controllable environment can thus assure accuracy in consistent and repeated testing. Environment can make much influence on performance qualification testing.

Comprehensive document

Comprehensive Document-Sourced:myinnovative

The documents for performance qualification should be comprehensive and thorough. Besides standard operating procedure, your documents should also include training part, maintaining part and so on. You should thus make the comprehensive documents which offered to all equipment user for standard performance.

Tractable data

Tractable Data-Sourced:reltio

The data of performance qualification must be tractable. You would better save data backup, archiving or make other plan for your data. The tractable data is the prove for integral and comprehensive performance qualification.

10.What Common ProblemsCan Performance Qualification Identify?

In your performance qualification phrase, there may be some problems. Here are some common problems which may be found from performance qualification and you may just relaxed when come cross with it.

Excessive heat

Excessive Heat-Sourced:slatesafety

The consistent testing of performance qualification may lead the excessive heating of equipment or instruments. For the excessive heat, you may just pause the operating and wait second for later operating. The insisting on operating while ignoring heating may lead problem on equipment or instrument.

Excessive vibration

Excessive Vibration-Sourced:memtechacoustical

Excessive vibration is also the common problems in testing for performance qualification. It may caused by various reasons and you may stop machines and solve the relative problems. Vibration may began in many occasion, just relaxed if it happened in your performance qualification.

Excessive noise

Excessive Noise-Sourced:magicvalleypublishing

The excessive noise just like excessive vibration or heat comes for various reason. You may just stop and repair it if it comes for the excessive operating. And you may also guarantee your performance qualification accuracy by making other test under the same circumstance to see its noise condition.

Process media back flow

Process Media Back Flow-Sourced:tvwd

Process media back flow when solution comes form one drainage pipe and went to another one. This may induce the bursting and product damaging. It comes from various reason from broke pump, plumping overhauling and so on. You should find the problem and make the timely repairing. For stricter results, you’d better test several more times on this part.

Pressure difference

Pressure Difference-Sourced:elgi

Pressure difference is also a common problem in performance qualification. The pressure difference may caused by liquid difference or environment. For this problem, you should find the cause and solved it. And then the more testing on this part may make more just results.

11.Are ThereOther Qualification For Equipment Qualification?

Have you ever wondered the existence of other qualification besides equipment qualification. There of course are other qualifications. Here are the other three representative qualifications for manufacturing besides performance qualification.

Design qualification

Design Qualification-Sourced:dr-sharayu-sawant

For many manufacturer, product designing is a deciding part. It decides the capability, manufacturer warranty, powder needs and so on especially for medical device. The safety and efficiency of device or equipment are also tested in this part. From design qualification, the performance and use of device are considered thoroughly.

Installation qualification

Installation Qualification-Sourced:sifo-medical

Installation qualification may find if your parts or components installed well according to manufacturer’s requirements. The successful installation qualification should follow the manufacturer’s guideline and requirements strictly. Installation qualification covers a wide range of process including inspection, documenting and so on.

Operational qualification

Operational Qualification-Sourced:angstromtechnology

After the meeting of installation qualification, operational qualification comes to make sure the equipment performance adhere to regulation. In operational qualification, the quality of instruments are inspected with great detail to ensure the great performance and productivity of relative equipment or device.

Conclusion

The complete FAQ guide in 2024 for performance qualification shows you the detailed information about this protocol. The deeper understanding of performance qualification may help you control your manufacturing process better. If you have any problem on performance qualification, you may just contact ALLPAK.

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FAT And SAT:The Complete FAQ Guide In 2024

Pharmaceutical Standard

FAT And SAT:The Complete FAQ Guide In 2024

There are many processes involved in the production and commissioning of equipment. Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) serve as two vital stages. The completion of acceptance at these two stage represents that the machine is qualified.

How much do you know about these two types of acceptance testings? Why are these two acceptance testing means so important? Are you curious about the similarities and differences between them? Do you know their procedures?

Well, today, let’s explore the complete FAQ guide of FAT and SAT.

Add a header to begin generating the table of contents

1.What is FAT?

Factory Acceptance Testing - Sourced: NSFLOW

The full name of FAT is Factory Acceptance Testing. As the name shows, FAT refers to the inspection of equipment at factory, that is, before it is delivered to customers.

During the factory acceptance testing stage, both the customer and manufacturer will take part in the acceptance at the manufacturer’s factory. The goal of this testing is to confirm whether the equipment meets the specifications as expected.

2.What is SAT?

Site Acceptance Testing - Sourced: Issuu

SAT, officially known as Site Acceptance Testing, is conducted after implementing FAT. This testing means refers to checking whether the equipment is functioning properly at the customer’s site.

There are several content involved in SAT. Generally, SAT includes inspections of the mechanical appearance, electrical wiring, and other aspects of the equipment.

3.Why is FAT and SAT so Important?

As two vital stages in the acceptance testing of equipment, do you know why FAT and SAT are important processes? If you are curious about it, let’s move on the importance of FAT and SAT.

Importance of FAT and SAT - Sourced: BF Group

According to the above figure, FAT and SAT are two important acceptance stages in the equipment production to delivery process. Strict acceptance criteria and detailed testing data are key to the successful execution of FAT and SAT.

For factories, FAT is important means to ensure product quality and production safety. Through professional testing, factories can discover problems and hidden dangers in the machine’s production process, and take timely measures to improve production efficiency and machine’s quality. In addition, FAT can also help factories comply with legal and regulatory requirements, avoiding fines and legal liabilities caused by illegal operations.

For customers, SAT is also an important way of ensuring product quality. User conduct site acceptance testing of the equipment to ensure that its performance and functionality meet expectations in actual usage environments. This step ensures that the system can work stably and reliably under actual operating conditions, and meet the needs of users.

4.What are the Benefits of FAT and SAT?

Why we need conduct FAT and SAT? These two stages play a crucial role in the delivery, installation, and commissioning of equipment. Through these two stages of acceptance procedures, it can be ensured that the equipment can operate smoothly and meet the needs of users. Are you curious about their detailed benefits?

(1)Meeting customers’ requirement

Meeting Customers’ Requirement - Sourced: protoplastics.com

Satisfying the customer’s need is the ultimate objective of product. FAT and SAT can check that the machine whether meet the customer’s requirements. Once the equipment passes the inspection, it can proceed to the next step.

(2)Safeguarding the quality of the equipment

Through professional testing of FAT and SAT, problems with the equipment can be identified and timely adjustments and repairs can be made to ensure the quality of the final product, and ensure that system components and overall performance meet industry standards..

(3)Saving time and cost

Saving Time and Cost - Sourced: Applied Performance

By conducting FAT and SAT, machine problems can be detected and reported to relevant departments for timely repair, thereby avoiding rework and maintenance costs caused by final product quality issues.

(4)Reducing risk

Reducing Risk - Sourced: 54 Collective

These two testing methods can avoid certain risks. By testing the system in a controlled environment, potential issues can be identified and fixed, reducing the risk of failure after on-site installation.

5.What are the Similarities between FAT and SAT?

We have learned that FAT is conducted at the manufacturing plant before shipment, and SAT is the on-site testing of installation after shipment to the user. As two acceptance testing, FAT and SAT testing methods have some similarities, mainly including:

(1)Quality and safety assurance

Quality Assurance - Sourced: Wise IT

The main purpose of FAT and SAT is to test the quality and safety of products and meet customers’ need before they are put into use.

(2)Requiring documentation

During the process of FAT and SAT, the test date and corrective behaviors need to be documented and a final FAT/SAT report need to be written.

(3)Comply with regulatory standards

Regulatory Standards - Sourced: The FAIR Institute

Both FAT and SAT need to be tested according to industry regulations and standards, which are set by agencies such as FDA and EMA.

6.What are the Differences between FAT and SAT?

Although FAT and SAT both belong to acceptance testing and have some similarities, there are also some differences between these two acceptance methods, mainly reflected in the testing site, environmental conditions, and other aspects.

(1)Testing site

Testing Site - Sourced: AIST Global

The biggest difference between FAT and SAT lies in the detection site. FAT is tested at the manufacturer’s location. SAT conducts testing at the customer’s location. After the equipment is successfully delivered to the user’s site, the user representative will conduct SAT to ensure that the performance and functionality of the equipment meet expectations in the actual usage environment.

(2)Environmental conditions

Because they conduct in different sites, the environmental conditions of the testing sites where FAT and SAT conduct are diversified, mainly displaying in compressed air or steam, temperature and humidity.

(3)Documentation

Documentation - Sourced: Zamann Pharma Support

FAT and SAT need documentation, and they are differed in the level of detail of the content. The information in the FAT documentation is more abundant than SAT documentation. FAT needs to undergo more functional and safety testing, with more specific and diverse testing content, in order to guarantee the quality of the product when it leaves the factory.

(4)Time

FAT and SAT are at different time stages in the completion of equipment. FAT conducts before delivering the machine to the customer, and SAT conducts after the installation of the machine.

7.What are the Procedures of FAT and SAT?

Due to the similarities and differences between FAT and SAT, their procedures also have similarities and differences. Well, let’s learn about their detailed process together.

(1)FAT procedure

The common FAT procedure goes through 6 stages, as follows:

Procedures	Description
1.Planning and preparation	Before acceptance, the staff need to develop a detailed acceptance plan, including the equipment to be accepted, the acceptance personnel, the acceptance time, and standards.
2.Visual testing	Checking the appearance of the equipment, mainly including components, labels, joint and painting. It is also necessary to check whether the instruments and accessories are consistent with the contract. In addition, it is necessary to check the wiring of the power supply unit, the input voltage of the power supply, and whether the nameplate is correct.
3.Functional testing	Conducting functional testing on the equipment, including charging and discharging cycles, adjusting parameters, etc.
4.Stability test	When conducting stability tests on the machine, continuous operation for 72 hours is required. Mechanical, electrical, or software adjustments cannot be made without the buyer’s permission.
5.Safety testing	Testing the safety of the equipment, including alarm function, to ensure compliance with safety standards and enable safety protection measures under fault conditions.
6.Documentation	Recording the results of the test and any issues that arise.

(2)SAT procedure

The common SAT procedure goes through 5 stages, as follows:

Procedures	Description
1.Preparation and installation	Before conducting SAT acceptance, it is necessary to make sufficient preparations for the equipment, including installation, debugging, calibration, etc. Preparing for equipment installation and debugging, and reading the FAT documentation. Installing the equipment by technical personnel from the manufacturer at the customer’s location.
2.Visual testing	Check for any damage or issues with the equipment during transportation.
3.Functional testing	Connecting the equipment to other devices and conducting functional testing on the equipment. For control systems, loop verification is a necessary step.
4.Inspection of User Requirement Specifications	Check the user requirements specifications to ensure that the design and functionality of the equipment meet the user’s needs.
5.Documentation	Record the results of the test and any issues that arise.

Overall, the processes of FAT and SAT can be repetitive, both the customer and manufacturer need to send engineers to participate in FAT and SAT, but SAT can detect issues that FAT cannot detect in actual environments.

8.What Items are Included on the FAT and SAT Checklists?

The Factory Acceptance Testing and Site Acceptance Testing Checklist is a comprehensive document that lists the standards, procedures, and requirements for evaluating and verifying the quality and functionality of machine and systems. All FAT and SAT checklists are not exactly the same, but they basically include the following points.

FAT and SAT Checklists - Sourced: Psychology Today

List of testing machines: This mainly records the names and models of the machines that need to be tested.

The reference specification list: It includes a series of related files involved in the FAT and SAT processes, such as dimensions, materials, and performance parameters.

Equipment calibration certificates: A calibration certificate for testing equipment is a document that proves that a specific device has been inspected, tested, and adjusted to meet specific accuracy and precision requirements.

Test data: After conducting functional, performance, and security tests, the operators record test results, including any issues identified during testing.

9.Why Is SAT Conducted After FAT?

One major difference between FAT and SAT is that they are in different time periods, and SAT needs to be conducted after FAT. Do you know the reason behind it?

Generic Project Life Cycle - Sourced: Secura

The picture above shows the generic project life cycle. When the equipment completes FAT, it can ensure the quality of the equipment before leaving the factory. During the transportation of equipment to customers, damage may occur. SAT can further detect quality issues and, when operated in actual environments, can detect problems that were not detected in the factory.

FAT mainly focuses on the manufacturing quality and performance of equipment, while SAT pays more attention to the reliability and stability of equipment in actual use environments. Therefore, site acceptance testing must be conducted after factory acceptance testing.

10.What Should be Considered When Conducting FAT and SAT?

In order to obtain accurate results, we need to consider multiple factors when conducting FAT and SAT.

(1)Using proper materials

Different Materials - Sourced: PixelSquid

Each machine uses different materials, including liquids, solids, and particles. Different materials can affect the testing results, and in severe cases, even the performance of the machine. Therefore, it is necessary to choose suitable materials according to the machine’s user manual.

(2)Training operators and technicians

Training Operators And Technicians - Sourced: Exelliq

It is necessary to enhance employees’ professional knowledge and skills, strengthen their knowledge of equipment testing, verification, and compliance. Technical personnel are required for guidance and installation during FAT and SAT. Operators need to constantly observe the operating status of the machine, identify problems and defects of the machine.

(3)Understanding user requirements specification

User Requirements Specification - Sourced: Post en Dekker blog

During the initiation phase of the project, users provide their expected usage requirements for the production equipment. This instruction needs to be combined with practical factors such as usage purpose, usage environment, and purpose.

Based on sufficient information collected, the equipment requirements should be provided as comprehensively as possible, and these requirements should be verifiable. The descriptions used in the URS should be clear, accurate, and measurable. These requirements include: Product and process requirements, regulatory compliance requirements, operational, maintenance, and technical requirements.

(3)Effective cooperation and communication

Effective Cooperation And Communication - Sourced: GenSight

Effective communication plays an important role in greatly improving work efficiency. Manufacturers and customers need strengthen cooperation and communication. During the FAT and SAT processes, effective communication is necessary to promptly adjust and resolve any issues that arise with the machinery and equipment.

Conclusion

FAT and SAT serve as a significant role in the acceptance progress of machines, which should be taken seriously to ensure the smooth delivery and use of equipment. Have you gained a better understanding of FAT and SAT after reading this article? If you have any further questions about acceptance testing, feel free to contact Allpack at any time.

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Installation Qualification Example: The Complete FAQ Guide In 2024

Pharmaceutical Standard

Installation Qualification Example: The Complete FAQ Guide In 2024

Are you trying to install equipment? Are you trying to minimize hazardous risks during installation? Installation is a must before successfully operating the equipment. Effective installation guarantees the smooth performance of any device. One must follow manufacturer specifications and recommendations to ensure error-free installation. How to verify that the installation conforms with standards?

Installation qualification is an indispensable procedure that ensures the instrument and systems’ safety, quality, functioning, and reliability. It is not only a good practice but also a legal requirement. People are always confused about the definition of installation qualification and what it entails. So, here is a FAQ guide “Installation Qualification Example: The Complete FAQ Guide In 2024” to satisfy ever-curious minds. Let’s look at the list of questions.

Add a header to begin generating the table of contents

1.What is installation qualification?

Installation Qualification- Picture Courtesy: Zamann Pharma

Installation qualification is a module of the process validation protocol that comprises a documented series of steps to assure manufacturers and regulatory bodies of effective delivery, installation, mounting, calibration, and arrangement of devices and systems.

It is the first step in the equipment qualification protocol and records every vital facet of equipment installation and verifies that these installation steps are carried out by following guidelines defined in the design specification, equipment manual, and in-facility user requirements.

Installation qualification provides documented evidence for the correct installation of the instrument and ensures that its installation will not severely impact its functioning. It verifies the installation and configuration of the machine, its components, piping, or service against a manufacturer requirement checklist. This step is performed before operational and performance qualification.

2.What is an installation qualification example?

Installation Qualification Example- Picture Courtesy: GF Machining Solutions

Whether your instrument is physical or digital, once you have configured it, here are some installation qualification examples for you to inspect your installation protocol:

Location Plan	Find a suitable location and ensure its suitability regarding floor space, ventilation, and outlets or drainage system.
Utility Inspection	Verify that various utilities, for example, water, electricity, compressed air, or other facilities are mounted as per design drawings.
Documentation	Collect and review every manual, certification, instruction guide, checklist, and other to verify the validity of every installation step.
Unpacking	Unwrap every piece of instrument and inspect them for wear and tear. Cross-check every step with the manufacturer's guide to ensure you are proceeding in the right way.
Component Verification	Install ancillary parts and other components, for instance, sensors, seals, screws, valves, etc. Ensure that they are fitted and aligned properly.
Recording	Note details like firmware models, serial numbers, and other instrument-related information.
Inspection of Environmental Setting	Examine and ensure that environmental and functioning conditions, for instance, temperature, humidity, and ventilation are according to manufacturer recommendations.
Software Installation	Verify that the updated version of the software is installed in the desired location. Check that the software is set up with correct settings and network accessibility and performs its core functions as anticipated.
Calibration	Carry out every component calibration or adjustment. Record these calibration procedures with their execution dates and tools.
Connectivity Validation	Check every connection and communication is established with secondary or supplementary support components in line with the user guide.

3.How does the installation qualification example serve industries?

Installation qualification example has central importance in ensuring performance and conformity of equipment and systems. It is a critical testing phase that has immense value in verifying the quality and efficiency of procedures in regulated manufacturing units. Let’s detail its important uses:

Compliance with Regulations

Compliance with Regulations

This process is a pivotal requirement for industries overseen by regulatory authorities, such as the FDA, EMA, or, WHO. It confirms that instruments are installed according to configuration parameters set by the manufacturers and governing bodies. Its records are typically inspected during regulatory audits. Therefore, fulfilling the installation qualification example is a failsafe way to meet GMP and ISO quality standards.

Risk Alleviation

Risk Alleviation- Picture Courtesy: PharmOut

This testing validation minimizes risks associated with incorrect installation of the instruments. Improper system installation and configuration could lead to erroneous measurements and faulty treatment procedures. Thus, the installation qualification example mitigates problems related to system malfunctioning, failure, and safety incidents.

Instrument Longevity

Instrument Longevity

The installation qualification example is a reliable approach to monitoring minor errors in the installation process that contribute to problems down the line and affect the working of the system. The rightly configured instrument generally has a lower component breakdown and lasts for many decades.

Records for Auditing

Records for Auditing

The documentation comprising installation qualification examples is a historical record of installation procedures and inspection checklists. It also documents details of operators checking installation parameters and errors that are rectified during the installation step. This report is integral for auditing productions and helps in troubleshooting technical issues that may arise in the future.

Decreasing Downtime

Decreasing Downtime

The installation qualification example serves as a guide for technicians to properly configure the machine first time. So, operational delays and expensive downtime are prevented by following correct installation standards. This also cut down the need for recurrent machine alteration and repairs, saving maintenance costs and operational time.

4.What type of industries need the installation qualification example?

Installation qualification is integral in laying the groundwork for process validation. Since it ensures the stable and effective working of the instruments; therefore, it is needed in various industries, including:

Pharmaceutical Industry

Pharmaceutical Industry- Picture Courtesy: Verywell Health

A wide range of equipment is utilized in the pharmaceutical industry to manufacture top-quality, safe, and potent dosage forms. Pharmaceutical machines, for instance, mixers, blenders, tablet presses, capsule fillers, granulators, etc., must be validated using an installation qualification example checklist to ensure they are fit for working and operate according to expected criteria.

Biotechnology Industry

Biotechnology Industry- Picture Courtesy: BioSpectrum India

Installation qualification example is a proactive step to reduce the adverse risks linked with the installation of biotech equipment, for example, incubators, centrifuges, chromatography devices, spectrometers, and bioreactors. This measure ensures that biotech systems are qualified for their proposed purpose. Therefore, it is indispensable in biotechnology industries for the efficient validation of research protocols and bioengineered products.

Medical Industry

Medical Industry- Picture Courtesy: Asimily

In the medical industry, the installation qualification example serves as an indicator of the safety and quality of medical devices and products. Proper installation of medical instruments- for example, sterilization units, diagnostic tools, surgical devices, etc.- is essential in patients’ treatment and safety. Any discrepancy in the installation of medical devices can jeopardize the life of the patient.

Food and Beverage Industry

Food and Beverage Industry- Picture Courtesy: Kompass Solutions

The installation qualification example is not just a regulatory requirement in the food and beverage industry; it is a significant measure to guarantee consistency in the food and beverage sector. It satisfies the safety and regulatory standards set by HACCP and ISO 22000 for the food industry. By following correct installation qualification examples, brands decrease contamination during manufacturing and build customer trust in the quality of their produced goods.

Chemical Industry

Chemical Industry- Picture Courtesy: Sigma-Aldrich

Different types of instruments- such as chemical reactors, distillation units, pumps, and heat exchange systems- are routinely used in the chemical industries. So, to comply with OSHA, EPA, RCRA, and, NPDES, the chemical manufacturers must perform installation qualification protocol. This validation protocol verifies that chemical equipment is safely installed and does not pose any risk to the operator and environment.

Cosmetics Industry

Cosmetics Industry- Picture Courtesy: More Natural

Compliance with GMP protocols is the first step to successfully marketing and distributing cosmetic products. Deviations in quality assurance steps directly affect the user's health. So, cosmetic brands follow recommended installation qualification examples to verify that their cosmetic products are designed by the highest quality standards.

Electronic Industry

Electronic Industry- Picture Courtesy: Integra Sources

Proper installation of manufacturing units- such as cleanrooms, water assembly systems, and testing tools- is pivotal in electronic and semiconductor fabrication. Thus, an installation qualification example is needed in this industry to verify manufacturing precision and prevent risks like electronic failure and fire incidents.

5.What are fundamental installation qualification example documents?

Installation qualification example is a prerequisite of any validation process and to confirm that it proceeds as required, one must have basic installation qualification example documents, including:

Fundamental Installation Qualification Example Documents

Installation Qualification Protocol

Installation Qualification Protocol

It is a detailed framework that documents the scope, strategy, and, measures to execute the installation qualification example. It further details:

Instrument identification essentials (version, product code, tag, manufacturer, vendor).
Name of devices and systems to be qualified.
Installation needs specified according to the manufacturer's guide.
Environmental conditions for installation.
A worksheet of approval criteria

Installation Qualification Checklist

Installation Qualification Checklist

It is a comprehensive specification list obtained from the installation qualification protocol, encompassing every facet of installation validation. It covers manual component inspection, utility installation, electric connections, calibration, hardware and software installation checkpoints, alignment, screw fastening, installation of axillary parts, and control schematics.

Installation Qualification Report

Installation Qualification Report

In this report, details of steps performed during the execution of the installation qualification protocol are mentioned. It offers a concise summary of detections, observations, and outcomes. Moreover, it explicitly expresses the acceptance or rejection of instrument installation criteria.

6.How do you fulfill the installation qualification example, step by step?

Installation qualification example is a structured procedure, requiring careful planning and a proper mindset. It can be subdivided into five major steps to achieve precise system validation. Let’s discuss step by step completion of installation qualification example:

Steps in Execution of Installation Qualification Protocol

Step 1: Preparation and Planning

Planning of Installation Qualification Protocol- Picture Courtesy: Dickson Data

It is crucial to prepare and plan by reviewing objectives and establishing the scope of installation qualification before starting installation tests. You should define what instruments and parts will be tested and make sure all the applicable facilities are available for installation qualification.

You should also specify how to handle any issue encountered during the qualifying procedure. Similarly, identify and assess perils associated with installation. This is critical to measure the severity and probability of risk and develop suitable risk alleviation approaches.

Step 2: Development of Installation Qualification Protocol

Development of Installation Qualification Protocol

After executing the preparation step, you should develop the installation qualification protocol. This code of conduct should mention the instrument or system, the name of the qualifying test, its methodologies, approval standard, rejection criteria, test outcomes, testing personnel, and date of testing.

It should enlist details of qualification testing to be performed, including assessment. It should specify the jobs, tasks, and responsibilities of personnel who will conduct the qualification process and who will evaluate and accept results. Moreover, references to documents used using qualifying procedures, variances handling, and modification adjustment procedures should be mentioned in the protocol.

Step 3: Implementation of Installation Qualification Protocol

Implementation of Installation Qualification Protocol- Picture Courtesy: Overbook Scientific

The skilled personnel carry out stated tests and examinations during this step to verify that the installation satisfies the preset approval criteria. In the execution phase, the proper installation of the instrument is verified, the calibration of devices is inspected, and the working of control panels is evaluated.

It is pivotal to adhere to the qualification protocol diligently and record the outcomes precisely. Also, any variances and abnormalities during testing should be documented and addressed accordingly. In this way, you can ascertain the reliability and traceability of qualification validation testing.

Step 4: Maintain Records of Installation Qualification Protocol

Maintain Records- Picture Courtesy: Freezerworks

Documentation is a key aspect of the installation qualification example because it offers records of testing tasks and verification of compliance, thus leading to simpler future inspections. It is recommended to document every piece of information like test figures, annotations, conclusion, installation details, qualification methodology, etc. in an explicit and systematized manner during the complete duration of the documentation phase.

This documentation must be detailed, precise, and readily available. This step also includes keeping version changes, utilizing regulated templates, and housing documents in a safe and centralized area in the facility.

Step 5: Review Installation Qualification Protocol

Review Installation Qualification Protocol- Picture Courtesy: Dickson Data

The last step in the installation qualification example is to assess and accept test outcomes and ancillary documentation produced during the qualification procedure.

The authorized personnel should inspect the qualification outcomes thoroughly to attest every prerequisite has been satisfied and if the installation is appropriate for its expected task.

In addition, they should meticulously read the documentation. They should attest that every investigation and examination is performed accurately, that approval criteria were satisfied, and any installation errors are rectified successfully.

7.What are ideal practices for the effective installation qualification example?

The installation qualification example should be executed diligently to avoid any inconsistencies during qualifying tests. So, here are some ideal practices that should be kept in mind to successfully carry out the installation qualification example:

Ideal Practices For The Effective Installation Qualification

Consider Risk Mitigation from the Start

Consider Risk Mitigation from the Start- Picture Courtesy: Soluen Engineering Solutions LTD

It is important to integrate a risk-grounded strategy early on into the installation qualification protocol for recognizing probable risks related to instrument installation and prioritize qualification strategies based on these risks. By this personnel can ensure that serious problems impacting product quality and safety are resolved first.

Go over Past Experiences

Go over Past Experiences- Picture Courtesy: ZipRecruiter

Review old installation protocols and documentation for the same device within the facility. This review can uncover frequent installation problems, which leads to proactive modification within the protocol.

Define Acceptance Criteria

Define Acceptance Criteria

Instead of specifying that the instrument must be configured according to manufacturer guidelines, you should precisely describe your quantifiable and specific approval criteria for every roadblock in installation. It clears any vagueness and ascertains that validation auditors empirically evaluate compliance.

Take into Account Future Flexibility

Take into Account Future Flexibility- Picture Courtesy: 35 North

It is best to plan the installation qualification protocol by considering future instrument upgrades or adjustments. A modular section in documentation helps in quick and effortless updates, which decreases the necessity of rewriting the whole document later on.

Utilize Visual Aids

Utilize Visual Aids

Ideally, illustrations, flowcharts, and, pictures should be included in the installation qualification example protocol to improve the clarity of installation guidelines and expectancies. This aids in easier understanding and implementation from technicians and validation teams. Visual aids- for example, comprehensive wiring figures- guide technicians and decrease installation errors.

Strategize for Environmental Factors

Strategize for Environmental Factors- Picture Courtesy: Renejix Pharma Solutions

Consider and plan for the effect of environmental settings (temperature, humidity, air) on installation steps. Incorporate any expected environmental controls- like keeping the temperature under the required limit – and inspections to guarantee that these conditions do not severely impact the equipment installation and operation.

8.How to troubleshoot frequent errors during installation qualification example?

Experienced people admit that installation qualification is a challenging job. Resolving these challenges is a crucial job in the validation process to ensure that the instrument is correctly installed, otherwise next stage of validation does not occur.

So, let’s discuss these frequent errors and their solutions during the installation qualification example:

Improper Utility Connections

Improper Utility Connections

The instrument does not start because of an incorrect or insufficient connection with electricity, water, gas, etc.

Troubleshooting

Look through the manufacturer’s guide for electric current, pressure, and, water flow to ascertain these utilities are properly connected. Manually examine connection points to verify they are connected with matching inlets or outlets. To test gas lines or compressed air connections, it is advised to use a pressure gauge. Moreover, a multimeter should be utilized to assess electric assembly. The utility diagram of the factory or laboratory should match with equipment requirements, if not then update it.

Component Misalignment

Component Misalignment

Sometimes, during the installation, mechanical parts, for instance, drives, sensors, conveyor belts, pressure valves, and more are incorrectly aligned or assembled.

Troubleshooting

First, physically locate any misaligned or loose components, for instance, belts, and gears, then dismantle those parts, and reinstall them correctly and tightly as per manufacturer specifications. It is advised to use precision orientation devices like a ruler, dial indicator, and laser leveling tool to correctly position and level components. Inspect different bolts, screws, nuts, and other rivets, to properly secure them.

Inaccurate Calibration

Calibration in Installation

Different accessory devices like temperature sensors, pressure gauges, piston gauges, and gas piston meters have inadequate, or unverified calibration ranges. Sometimes, these instruments are found out of calibration during installation qualification.

Troubleshooting

To address this challenge, you should first look for valid calibration certifications for every vital piece of equipment and if they are outdated then renew their calibration. If required, you must carry out in-house calibration with standard calibration reference. Also, document every calibration outcome in the installation qualification protocol and note any anomaly and actions performed to encounter during this process.

Unsuccessful Safety Assessment

Unsuccessful Safety Assessment- Picture Courtesy: Fluke Corporation

During installation qualification, there comes a time when safety components, such as emergency stop buttons, alarm lights, interlocks, gaskets, and valves fail to meet safety criteria because they are non-functional or incorrectly fitted.

Troubleshooting

To rectify this installation error, inspect wiring and other connections of different safety features, and verify that they are wired and assembled properly according to the manufacturer's standards. Activation of safety instruments should be checked by inducing unsafe settings in the facilities. Replacement of faulty instruments must be carried out with certified components. Last but not least, it is suggested to contact the manufacturer for troubleshooting support if the device still fails to work after following the above instructions.

Labeling Slipups

Labeling Slipups- Picture Courtesy: Marcajes Telleria

Systems or other crucial devices are not correctly labeled, or have missing identification tags, causing mix-up during processing or maintenance.

Troubleshooting

It is recommended to solve this issue by going along with these suggestions like cross-checking the labeling stipulations from the installation qualification with manufacturing standards. Place correct, long-lasting, and, clear labels or tags on every part, utility, wiring, or piping. Installation qualification documentation should be updated to indicate precise labeling items for the upcoming review.

Conclusion

Installation qualification example in an integral procedure in the validation process to confirm proper installation, configuration, and functioning of any system, equipment, component, and, software. By following the step-by-step instructions and complying with the best practices mentioned in this blog post, you can efficaciously and lucratively conduct installation qualification examples, mitigate installation and operational mistakes, and satisfy stringent regulatory standards for your business and facility. Now, if you are keener on learning about installation qualification protocol for validation of routine industrial devices, you are highly encouraged to contact Allpack through our messaging or email service.

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