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.

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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.

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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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DQ, IQ, OQ, PQ In FDA-Regulated Industries: The Complete FAQ Guide In 2024

Pharmaceutical Standard

DQ, IQ, OQ, PQ In FDA-Regulated Industries: The Complete FAQ Guide In 2024

Have you ever heard of DQ, IQ, OQ, or PQ? In FDA-Regulated industries, every piece of equipment and system is hooked to proper regulations. This means each step and protocol is jotted down in specified protocols. Why is it required to have verified documentation? What happens if your equipment is missing functional specifications?

In this article, we have talked about from basic to advanced literature about DQ, IQ, OQ, PQ in FDA-regulated industries. Stay on this page if you have less time and more questions in mind. We have explained the topic with interactive illustrations and examples to make you learn about these important certifications required in FDA regulated industries.

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1.What are DQ, IQ, OQ, PQ In FDA-Regulated Industries?

FDA

DQ, IQ, OQ, PQ in FDA-Regulated Industries

To understand the answer, you should first grasp what are FDA regulated industries. Actually, FDA is mainly meant to ensure safety and protection. Especially when it comes to dealing with medicines, biologicals, and items associated with health and medicine. Therefore, it is particularly important when you’re producing goods for foods, humans, pets, etc.

So, the FDA or Food and Drug Administration USA has regulated some essential rules and regulations; and is responsible for maintaining them.

In the pharma industry, you cannot deny accuracy and safety. You should know that any slight mishandling or error can cause potential hazards to patients. Subsequently, the reliability of equipment is paramount. DQ, IQ, OQ, PQ in FDA regulated industries is providing a promising way that certifies the current equipment and procedure is compiled with reliable performance and results and ensuring client safety.

2.What is DQ?

DQ- Picture Courtesy: MGA Techonology

This is ‘design qualification’ which is utilized in several industries like pharmaceuticals. It ensures that the system design is exactly according to regulated specifications. The DQ is mainly carried out when you are at the beginning of any project development; that promises you the machine is up to the mark with high-quality standards.

The DQ is associated with deep evaluation of design documentation involved with specifications and structural framework of the equipment. Hence it certifies that the design is complete with all possible essential documentation.

The prime objective of DQ is to immediately identify the structural flaws of equipment. Side by side, it ensures that equipment is compliant with FDA regulations and the establishment of the records relevant to the unit.

It is involved with the needs of users as well as user specifications. That requires a detailed design format with review and approval of the machine by various personnel such as engineering teams, quality analysts, and stakeholders. Test and simulation and risk analysis (safety features), record keeping, and final approval.

3.What is IQ?

Installation qualification- Picture Courtesy: Access Industrial Solutions

So, once you confirm that the design qualification of equipment is up to the mark therefore the next task is the installation of the unit. Do you know how your system implements the experimentation? It is all based on the right installation.

FDA-regulated industries mainly focus on IQ whenever install a piece of new equipment and it is called an ‘Installation Qualification’ or IQ. It is actually a verification document that certifies that your system is qualified and configured as it is promised in its specification. For that, you can mostly refer to the installation checklist mentioned in the manual of the machine-generated by the manufacturer.

Moreover, the IQ that is involved with methods should be well-documented and included in the ‘Validation Master Plane’ or VMP.

The compulsory steps involved for IQ are mainly outlining the methods and conducting assessments. That is mainly involved with the verification of the machine and things associated with it. It is included with the specifications given by the manufacturer. Moreover, the installation conditions such as area and temperature around the equipment, electrical essentials, and software installation.

4.What is OQ?

Operational Qualification- Picture Courtesy: Tien Tuan Pharmaceutical

Whenever you check IQ, it is parallel to performing the OQ or operational qualification of the equipment. As its name shows, it is an assessment to analyse the operational performance of the equipment as per your needs. The purpose of this verification is to ensure that whatever your manufacturer claimed is really performing in your functional range. This means it is mainly performed to identify the properties of the unit and ensure its seamless operation.

To perform this test, the plan sheet provided by the manufacturer or regulated body is properly checked and accepted by the facility once the test is successfully conducted.

The essential steps for OQ involve a thorough inspection of the unit. It means, the inspection of software and hardware, how to start and run the test, and assessing the safety protocols. Moreover, the test run is conducted to ensure that the machine is providing you the fruitful results hence you can confidently run the machine hereafter.

5.What is PQ?

Performance qualification- Picture Courtesy: Contract Pharma

This is the final step which is assuring the absolute functional capability of the equipment. The performance qualification or PQ promises you that the unit will offer a consistent output for a long period of time.

The pharmaceutical industry considers PQ as a major asset. Consistency and high throughput are what every pharma looks for to generate high-production batches and meet healthcare needs. Therefore, the test ensures that the functionality, installation, and efficacy of the machine are up to regulatory standards.

6.Why DQ, IQ, OQ, PQ In FDA-Regulated Industries is essential?

Every FDA-regulated industry like medicine, pharmaceuticals, research, biologicals, and others cannot work without addressing specified compliance requirements. So, there are multiple reasons to implement DQ, IQ, OQ, PQ in FDA-regulated industries. What are those points? We have discussed them below so have a look at them.

You Can't Ignore FDA regulations

FDA regulated Protocols

As per FDA statement in 21 CFR Title 211.63, the equipment utilized for processing, packaging, and overall manufacturing of medicinal items must be in accordance with the correct in structure, and sizes, and up to suitability of the facility to bring operation and for cleaning as well as maintenance. So, it is the responsibility of the manufacturing company to bring you unit with up-to-the-mark features.

It should be provided with detailed instructions and usage properties. That includes how to operate, clean, and maintain the unit to give it an effective application.

Make Patients Safe & Ensure Quality Product

Safe and quality preparation- Picture Courtesy: Makinew

When you’re manufacturing any medicine or product in your plant; slight mishaps, mishandling, or problems in the unit can lead to severe consequences for you and the patient. This is commonly referred to that equipment which is new without any history. Therefore DQ, IQ, OQ, PQ in FDA regulated industries make you pretty safe from failure in performance or error in the making of medications.

It creates everything in well-documented pieces of evidence and verifies the hardware and software of the units. So, what’s next? It makes lesser chances of incorrectness and makes you ensure that equipment is passed with design till its final performance with reproducible output. Thus, you can ultimately get a good quality product.

Your Facility is Compliant

Quality standards- Picture Courtesy: Microsoft news

Every pharmaceutical industry must be compliant with FDA regulations. Following the documentation for equipment installation meets all needs that are set up by FDA. The verification for DQ, IQ, OQ, PQ in FDA regulated industries ultimately minimizes the chances of batch withdrawal or recalls and saves your budget.

No Failure and Early Management

Minimize interruption- Picture Courtesy: WIPO

Every manufacturing industry keeps processing its protocols 24/7. Hence, there are high chances of failure. The strict adherence of DQ, IQ, OQ, PQ in FDA regulated industries helps you in the identification of issues at the beginning.

When you consider DQ, it assures you that the purchase unit is strictly designed with quality standards. Similarly, IQ, OQ, and PQ assessments are thorough testing assuring everything about the processing and future protocols.

Therefore, once you’re well aware of every stage will have high confidence in operating, identification of problems, and early troubleshooting.

Record Keeping

Verified data- Picture Courtesy: Vaisala

Implementation of DQ, IQ, OQ, PQ in FDA regulated industries allows verified records related to equipment from its making to processing. You can easily trace the history required for various activities in pharmaceuticals and related companies. So, you can have a clear picture with easily identifiable issues about the unit.

Offering Good Training and Knowledge

Good knowledge- Picture Courtesy: Technopharm

Bringing a new setup into your facility will allow your employees to facilitate training and gain good knowledge during the DQ, IQ, OQ, PQ approach. By this, a group of workers understands the protocols, relevant troubleshooting, and extensive knowledge that ensures your team is well aware of the work process and handling.

Good relationships with Vendor

Good relationships with vendor- Picture Courtesy: Pharmaceutical Technology

During DQ, IQ, OQ, PQ, and verification, you may discuss general matters and discussion about equipment closely. It directly opens the gateway between you and the vendor and can carry it out for long-term professional relationships.

7.What type of sectors utilizes DQ, IQ, OQ, PQ In FDA-Regulated Industries?

You cannot ignore the implementation of DQ, IQ, OQ, and PQ in FDA-regulated industries. What are those industries? Let's discuss how each of these plays a significant role with examples accordingly.

Pharmaceutical Industry

Pharmaceutical equipment- Picture Courtesy: Korber Pharma

This is the major core to produce medicines. Whether oral, parenteral, topical, or powder medicines; a minor error can result in risky outcomes. It directly affects your expenditure and delay in processing. Therefore, whenever a new set of equipment is installed in a pharma facility.

The series of tests DQ, IQ, OQ, and PQ are followed to ensure conformity with regulatory standards. This general qualification activity guarantees that the manufacturing process satisfies all requirements and provides you with quality products.

Biotechnology Industry

Biotechnology assays- Picture Courtesy: faCellitate

In the biotechnology industry, absolute working is needed when dealing with delicate assays, sampling, and cell culture procedures. The necessities for DQ, IQ, OQ, PQ are paramount as the functioning equipment for biotechnology tasks ensures reliable and efficient performance.

Due to conduction with sensitive testing related to genomic alteration, molecular level, cellular level, and blood sampling in biotechnology; the safety, effectiveness, and purity must be maintained by strict following up of FDA regulations.

Medical Devices Industry

Medical Devices Industry- Picture Courtesy: SJRA

It is essential to qualify the equipment used for manufacturing and packaging procedures for the medical devices industry. However, under real conditions of production, it will deliver medical devices and parts with high quality, thereby, the products manufactured will be totally safe for patients and end-users. For example, X-ray machines, CT- Scanner, implantation devices, or radiology medical equipment.

Food Industry

Food industry- Picture Courtesy: Redline

In the food sector, safety related to raw ingredients, manufacturing, filling, and packaging plays a significant role. For this, your equipment must have adhered to DQ, IQ, OQ, and PQ documentation to ensure the system is well-functioning and compliant with regulatory requirements.

Nutraceutical Industry

Nutraceutical Products- Picture Courtesy: Market Research Intellect

Just like pharmaceuticals and food, the nutraceutical industry also undergoes strict testing and production of goods related to human consumption. Most of us the equipment used in nutraceuticals is derived from natural sources that offer wellness to you.

Therefore, DQ, IQ, OQ, and PQ confirm that the design of the machine conformed with all the requirements and conditions needed for manufacturing products under the required conditions.

Veterinary Industry

Veterinary Industry

There is a surging need for good quality veterinary products nowadays. This field of production is equally important as the above-mentioned FDA-regulated industries. The life and health of animals must be dealt with by medicines or energy-boosting products that are manufactured with strict conformities by regulatory bodies.

The DQ, IQ, OQ, and PQ documentation significantly emphasized that the current units used for the preparation of products, such as solid dosage, parenteral, or liquid formulation for your animals are safe and prepared by FDA-approved equipment.

8.How to execute DQ, IQ, OQ, PQ In FDA-Regulated Industries?

Typically, the pharma and related FDA-regulated industries focus on the following steps for the execution of DQ, IQ, OQ, PQ. For instance:

Design qualification- Picture Courtesy: GEA

DQ is mainly verified by the following three steps.

Step 1	Here, it involved double checking of ‘purchase order’ as well as the ‘user requirement specification’. In many cases, the purchase order is also termed as a ‘request for purchase’. The purpose of this step is to ensure that manufacturers agree to offer the following properties, specifications, and materials are mentioned in the document and well-engineered.
Step 2	This section is hooked to detailed design specifications of the equipment that must be compliant with the drawing as presented to their customers and provided with updated features.
Step 3	You can term it as the final step where you can have a deep inspection of the overall presentation of the product and prepare a summary related to the equipment.

Installation Qualification

The IQ process is verified by the following steps:

Step 1

In this step, you will need to check the identification of the new equipment that is involved with the series, model number, type, automation, brand, etc.

Step 2

It is involved with the series of equipment and the qualification system as the installation requirement provided by the manufacturer's specification.

Step 3

The entire favorable condition is verified by checking the temperature of the installation area, measuring the humidity level, monitoring the electrical connections as well as assessing the machine’s calibration. The final report is prepared once all evaluation is done.

Operational Qualifications

OQ verification is performed to ensure that the equipment is operating properly as specified by the manufacturer. There are the following steps to make a successful OQ processing.

Step 1	The detail of the system, its software and hardware, and its operation is evaluated to check if the operational specifications is compliant with FDA regulations.
Step 2	The step-by-step running of the machine is conducted out and various operating tests are carried that are highlight operation with surrounding conditions. Here, you can also create intentional failure situations and simulate the error modes to learn teamwork with troubleshooting for unexpected circumstances.
Step 3	The result is summarized by observing all major details and possible recorded deviations and the corrective actions. The elaboration of each step in OQ validates that the unit is reliable and highlights the various risks and handling to enhance operational comprehensiveness.

Performance qualification- Picture Courtesy: Chemtech

The performance qualification steps are:

Step 1

The real-time assessing tools are techniques are implemented to monitor the data by PQ execution, here you can integrate various sensors as well as utilize software to analyze critical parameters.

Step 2

Furthermore, process analytical technology or PAT is offered to assess the quality and performance of the system.

Step 3

Also, the process capacity and design protocols are considered to evaluate the final limit of the production requirements. For example, if your recent production is 50, so in the future if it reaches above 100 then the PQ conduction test would verify that the process would be successful without affecting the quality of products.

9.What are the challenges of maintaining and designing DQ, IQ, OQ, PQ In FDA-Regulated Industries?

With DQ, IQ, OQ, PQ In FDA-regulated Industries' usual strategies, you also encounter some challenges. We have discussed some major issues and their solutions.

Inadequate Planning and Scope Definition

Complex planning and scope

Problem

Solution

One of the major issues in initial planning is vague or ambiguous requirements to be addressed by qualification, which most often brings gaps in documentation and compliance.

Now, a very vague scope can introduce uncertainty in particular validation needs, and such things may eventually be left out of the qualification process.

therefore, stress over scope definition and clarity of requirements. Teams often compromise full documentation in order to meet very tight deadlines and miss all the critical steps.

Precise Requirements Definition
Engage with stakeholders as early as possible—quality assurance, engineering, and operations teams—to make sure that all requirements are clear and complete from the beginning so that all aspects of the validation process are understood by everyone involved.Clean Scope Documentation

Develop a Validation master plan (VMP) that defines the scope of qualification, objectives, timelines, and contact responsibilities for each phase of qualification.

The plan is supposed to be a roadmap that will cover the topic clearly and result in full compliance with standards that have been laid down by regulatory bodies.

Clearly defining the scope and involving stakeholders leads to reduced risks of compliance and documentation gaps for companies.

Requirement and Fulfilling of each Phase

Utilization of regulation- Picture Courtesy Pharmaceutical Processing world

Problem

Solution

Each qualification including DQ, IQ, OQ, and PQ has different requirements and expectations, thus making the general process somewhat complicated. Since regulatory bodies like the FDA have to issue constant upgrades, it can get complicated for organizations to keep up with new norms.

Standards and guidelines of regulatory agencies, which are very often updated, may leave some gaps in qualification as companies cannot update fast enough.

Risk-based approach
DQ, IQ, OQ, and PQ efforts should highlight the critical parameters and processes. Therefore, most risks need importance in the consideration that it complies with and is safe for the product being produced.Continuing Education and Training
Regular and continuing training programs should be implemented so that all personnel will be current on all regulatory requirements, best practices, and new or additional standards or guidelines issued by agencies such as the FDA.

Regular regulatory review
It should be set up to have a continuous process of reviews of changes in regulations and adapt qualification procedures accordingly to keep pace with the changes in standards and minimize the risk of nonconformity. Interpretation of these updates by a dedicated team or system would have been an immediate prerequisite for adaptation.

Data and Documentation Management Challenges

Data and Documentation Management

Problem

Solution

The DQ, IQ, OQ, PQ may generate huge amounts of data, making it very hard to manage accurately and in a timely manner, hence increasing risk for errors and delay in compliance.

Heavily documented needs can sometimes be incomplete, inconsistent, or simply inaccurate records. The lack of information about suppliers and manufacturers, coupled with the validation process, has hollowed credibility as well as compliance.

Advanced-Data Management Tools

Think then about the modern data management solutions that would simplify collection, storage, and analysis. Even the usage of electronic systems must improve accuracy, tracking, and reporting for requirements.

Document Management System

Secondly, a comprehensive document management system should be adopted and standardize formats of documents automatically, whereby all documentation processes are automated. This minimizes the chance for error and increases consistency, further simplifying retrieval and review during audits or regulatory checks.

Inadequate or Missing Reports

Report issues- Picture courtesy: Zamann pharma

Problem

Solution

Reports may be incomplete or lack clarity, hindering effective decision-making and compliance verification.

Report preparation templates

Implement the use of templates whereby all reports have full details, easy to communicate, and are in similar formats for easier understanding.

Inconsistent Systems and Protocols

Inconsistent Systems and Protocols- Picture Courtesy: EESS

Problem	Solution
In the present system, different departments follow one single procedure for validation. Most equipment types lack standard operating procedures for qualification and their results vary. It means that either the protocols are vague, wrong, or incoherently defined. Thus, inaccuracies are introduced within the qualification process.	Standard operating procedures (SOPs) Standardize all the SOPs. This shall include qualification for a uniform process and documentation across this will certainly assure consistency and rule out errors from the fragmented processes.

Continuous Monitoring and Review

Continuous Monitoring and Review

Problem

Solution

Maintaining control and oversight overqualified systems can be challenging, leading to potential lapses in compliance.

Standard Review Procedures

Implement a process of continuous monitoring and auditing so that the qualified system continues to remain in compliance with regulatory standards and operational requirements.

Conclusion

The path of adding new equipment in your medical facility, pharmaceutical, biotechnology, etc is absolutely striking with challenges. But if you follow the right strategy and ideal resources that are compliant with FDA regulation can limit the obstructions. We would suggest if you have any problem or need to seek some advice, then always approach the right solution and experts who can solve the complexities during the regulatory issues. Why not contact us? We are a team of advisory professionals and manufacturers who strive for your support and guidance. For more information or FDA-regulated equipment for your production line, contact the Allpack team now.

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