Performance QualificationThe Complete FAQ Guide In 2024

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-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.