Performance Qualification - Run 3 batches and ready, right?
Great, you finished the OQ, found your process window, and now must show the consistency of your process. The performance qualification (PQ) should be an easy part if you made it until here.?
This post talks about:?
What is a PQ, and why perform it??
The GHTF (Global Harmonization Task Force) defines performance qualification as “establishing by objective evidence that the process, under anticipated conditions, consistently produces a product which meets all predetermined requirements.” [2]?
?The performance qualification’s key objective is to run the process at normal conditions and demonstrate the process consistently produces acceptable products [2]. This means that several batches are produced [1].?
Running 3 batches at normal settings?
Yes, it is a myth that you must run three batches - Sorry. The U.S. FDA deleted the requirement for testing from the first three production batches [5]. The ISO 11607-2:2019 mentions under 5.4.4 that at least three production runs shall be included [4]. Taylor mentions that running a PQ involves multiple lots of production [1]. The number of batches you should produce is a sample size like any other and must be justified why it is a certain number. In order to determine the number of batches, it is essential to understand the process variations and influences to which the manufacturing process may be exposed [3].?
?Possible influences to consider are:?
?The results of OQ and PQ also include the development of characteristics for ongoing monitoring and maintenance [2].?
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Can we sell PQ parts??
The PQ intends to produce products at normal conditions (same conditions, processes, procedures, materials, etc.). So, to answer the question: Yes, if the products meet all release criteria, they can be sold.?
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References?
[1] Taylor, Wayne (2017). Statistical Procedures for the Medical Device Industry. Taylor?
Enterprises, Inc., www.variation.com?
[2] https://www.imdrf.org/docs/ghtf/final/sg3/technical-docs/ghtf-sg3-n99-10-2004-qms-process-guidance-04010.pdf?
[3] https://www.quality-on-site.com/get.php?fileid=139?
[4] ISO 11607-2:2019 Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes?
[5] https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart?
=820&showFR=1?
Assistant Project Manager at Zeito Plastic Components
12 个月Hi, So the no. of PQ batches & hours are depend on type of process also typical production time? Is it this still can be plan between Quality & Process team to decide? Thank you.