Performance Qualification - Run 3 batches and ready, right?

Updated: Sep 28

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 a PQ is and why perform it

  • Running 3 batches at normal settings

  • Whether you can sell PQ parts

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:

  • 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 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.

Are you concerned about the increased requirements due to MDR (Medical Device Regulation; 2017/745) and already behind schedule? Contact us today, and we'll take the burden off your shoulders and help you make your supply chain compliant.


[1] Taylor, Wayne (2017). Statistical Procedures for the Medical Device Industry. Taylor

Enterprises, Inc.,



[4] ISO 11607-2:2019 Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes



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