Re: Requirements of Contract Mfg. in respect to GMP?
Under 13485, a contract manufacturer of medical devices per se has only those responsibilities that it agrees to assume or share per its contract with the Manufacturer; and, those responsibilities to which it is subject under specific medical device rules and regulations. In general, full responsibility for the contract manufacturer's actions and operations is assigned to the Manufacturer.
I assume that by "GMP", you mean the US FDA-supervised 21CFR820 QSR body of rules, plus related rules and guidances. (As opposed, for instance, to the Japanese GMPs.) I'll use the term " US FDA QSR" for better clarity here.
Under the US FDA QSR, a contract manufacturer of medical devices per se has the same responsibilities as above, relative to US federal regulations, but with exceptions:
1. If you are implementing validated processes, the FDA may assign you full co-responsbillity for the validation and operation of those processes.
2. If your operations involve special expertise for critical operations (for instance, your business role is as a contract sterilization service provider, or a device sterile-barrier-packager, or you conduct clean room operations), the FDA will assign you full co-responsbillity for the validation and operation of those processes.
3. If separately from your contract manufacturing activities, you also are a registered medical device manufacturing Establishment and have device products of your own, the FDA may (and based on recent instances, will) assign you an elevated extent of responsibility for your contract manufacturing activities "because you're supposed to know the rules". This can extend to unannounced FDA inspections of all of your operations if an inspection of your contract manufacturing customer causes the FDA to believe that that other company has not been controlling you adequately and there is a possibility that the products you make for them are thereby not safe and effective.
NEEDED.....a brief summary of the differences between ISO 13485 and GMP for contract manufacturer. We do not make final medical devices, but component parts. Customers want components made under GMP. This is a re-occurring question. We are currently ISO 9001 and soon to be ISO 13485...Management wants a clear response to address customers needs...an explanation of difference in terminology and standard requirements for a contract manufacturer's perspective.
