Thank you Mark.
It is important to reinforce that companies hire outside contractors for their specific expertise and capabilities. This does not mean that you give up responsibility that the operation be compliant and performed properly, but it also doe not mean that you must dictate how they do the job for which you have hired them. This is the reason that Purchasing controls become critical.
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Couple further comments:
Many thanks Mark for your additional emphasis on the merits of not having a detailed (or any) process validation procedure when process validation is outsourced. As noted before, that approach is certainly permitted by ISO 13485, and as mentioned, is one that I, and I'm sure many others, have used before. That approach certainly has its own practical and very valuable merits.My general preference remains that it's a good idea in my opinion to have a proper process validation procedure in place for the reasons I stated before and because I feel there is value in being proactively prepared for the likely eventuality that the process validation stars don't always stay perfectly aligned regarding process validation competencies and cooperation between the organization and its contract manufacturers. I also think that such a procedure can bonify an organization's claimed ability to responsibly, properly, oversee the contract manufacturer. That in turn can boost regulators' confidence and reduce their suspicions when they review the contract manufacturer's process validation work during audits of the OEM. For example, I remember being in a recent agency inspection involving recall where the investigator was suspicious of the contract manufacturer's process validations. A good process validation procedure can be a useful and objective way to systematically show that the organization takes its process validation oversight seriously, and that it has the organic competence to distinguish proper process validation from deficient process validation. But as acknowledged before, there may certainly be scenarios where an abbreviated or delegated process validation procedure is acceptable. Thanks again Mark for your valued insights.
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