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  • 1.  Process Validation documentation

    Posted 25-Aug-2022 07:44
    Hi all,
    I have a contract manufacturing site that prefers to combine their process operational (OQ) and performance qualification protocols (PQ) into one protocol and then into one report. They used to  only make components and simple assemblies and are now moving into manufacturing finished devices.
    I'm not used to seeing it done this way and it makes review difficult for the Quality team and auditors. I'm used to one OQ protocol, followed by one OQ report and then one PQ protocol, followed by one PQ report. I'm even willing to see OQ and PQ be in one protocol,  which is risky of course, but to also have one report doesn't make sense. Shouldn't PQ be based on  data analysis and conclusions from OQ?

    I want to understand if there is a requirement/guidance that clearly states that separation is required. If not, we will be flexible, even though it is not user friendly.
    Thank you

    Kate Bartelli
    Maple Grove MN
    United States

  • 2.  RE: Process Validation documentation

    Posted 25-Aug-2022 11:13

    Process validation applies when full verification is not possible or desirable. The paradigm case is a destructive test.

    By convention, process validation has three elements – IQ, OQ, and PQ. These are not regulatory requirements and are not the only way to do it. The idea is to achieve the goal as started in 820.75(a), "validated with a high degree of assurance". This is assurance that when the process is operated correctly there is a high degree of assurance that the process does not produce non-conforming product.

    Achieve the goal by defining the parameter space of the process inputs and the nominal operating point. OQ determines them and PQ checks that they work. Combining them into one protocol and report is not a problem.

    Since process validation is done only one time, unless there are process changes, it should not be an issue. An important point is assuring the parameter space and operating point are correct in the production documentation. Another important point is that the operators follow the monitoring and control requitements and record the data.

    FDA/CDRH does not have any guidance documents or regulations on how to conduct process validation. There was a time, many years ago, when FDA/CDRH planned to adopt the GHTF guidance document, but that never happened.

    My first recommendation is don't worry about the documentation format as long as the contract manufacturer follows their own procedures, determines the parameter space and operating points correctly, and correctly implements them in the production documentation.

    As your contract manufacturer you could amend the contract to require a specified format for process validation. It will cost you a lot of money, won't add value, and won't give you a better device.

    Dan O'Leary CQA, CQE
    Swanzey NH
    United States