Performance Qualification (PQ) – Run 3 Batches And Ready, Right?
Simon Föger
"establishing by objective evidence that the process, under anticipated conditions, consistently produces a product which meets all predetermined requirements."
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 Performance Qualification 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:
- Temperature
- Humidity
- Variations in electrical supply
- Vibration
- Environmental contaminants
- Purity of process water
- Light
- Human factors (training, ergonomic factors, stress, etc.)
- Variability of materials
- Wear and tear of equipment
- Machine set-up
- Change-over procedures
- Process start-up and restart
- Multiple shifts
The results of OQ and PQ also include the development of characteristics for ongoing monitoring and maintenance [2].
Check out our video about Performance Qualification (PQ) in MedTech – How many runs do you have to produce for a PQ?
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Further helpful links and resources:
- SIFo Medical YouTube: Short, valuable videos on Quality Management
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- TMV Guides: Your practical guide to perform test method validation (incl. templates & videos)
- TMV Online Course: Become an expert in Test Method Validation
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References
[1] W. Taylor, Statistical Procedures for the Medical Device Industry. Taylor Enterprises, Inc., 2017. [Online]. Available: www.variation.com
[2] Global Harmonization Task Force (GHTF), “Quality Management System – Process Validation Guidance,” GHTF/SG3/N99-10:2004, 2004. [Online]. Available: http://www.imdrf.org/docs/ghtf/final/sg3/technical-docs/ghtf-sg3-n99-10-2004-qms-process-guidance-04010.pdf. [Accessed: Aug. 7, 2025].
[3] Quality-on-site.com, “ISO 14971 Risk Management Presentation.” [Online]. Available: http://www.quality-on-site.com/get.php?fileid=139. [Accessed: Aug. 7, 2025].
[4] International Organization for Standardization, ISO 11607-2:2019 — Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes, Geneva, Switzerland: ISO, 2019.
[5] U.S. Food and Drug Administration, “Quality System Regulation – 21 CFR Part 820.” [Online]. Available: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820&showFR=1. [Accessed: Aug. 7, 2025].