Great, you finished the Operational Qualification (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 Performance Qualification (PQ) & Why is it Relevant in MedTech?
Running 3 Batches at Normal Settings
Can You Sell Performance Qualification (PQ) Parts?
What is Performance Qualification (PQ) & Why is it Relevant in MedTech?
The GHTF (Global Harmonization Task Force) defines Performance Qualification (PQ) 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 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].
Can You Sell Performance Qualification (PQ) Parts?
The Performance Qualification 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, you can sell PQ parts.
Author: Simon Föger
Are you unsure how to perform a Performance Qualification yourself?
Contact us today at office@sifo-medical.com, and we'll gladly assist you in conducting a Performance Qualification.
PS: Check out our SIFo Medical YouTube channel if you want to learn more about Quality Management in MedTech.
References
[1] Taylor, Wayne (2017). Statistical Procedures for the Medical Device Industry. Taylor Enterprises, Inc., www.variation.com
[2] http://www.imdrf.org/docs/ghtf/final/sg3/technical-docs/ghtf-sg3-n99-10-2004-qms-process-guidance-04010.pdf
[3] http://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