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
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Kate Bartelli
Maple Grove MN
United States
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