Requirements of Contract Manufacturing in respect to GMP?

[MIREGMGR]

Assuming that your company has no role in distribution of finished devices, and your components are not directly at fault in a harm-to-patient incident, you should be fine.

 

[Doug Tropf]

Well said. I believe the second "are" in the last sentence should be "our".

 

[Phil Fields]

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.

You are component manufacturer, not a finished device manufacture, as you stated above. The scope of 21CFR Part 820 (a).1 and .2 define the regulations to be for Finished Devices, components are not regulated.

Is there a specific reason why your customer is making this a requirement? Have you asked your customer to perform a gap analysis to be able to conform to the GMPs to their satisfaction?

Phil

 

[markl368]

I think your statement is a good one for your customers. You don't make finished devices, but FDA is clear that contract/component manufacturers are still an extension of the finished device maker's manufacturing process, so you need to operate your processes in accordance with meeting you customer's responsibilities to ensure process controls, quality checks, and validation meet requirements.

Also, you should be aware that although ISO 13485 was previously a document linked directly to ISO 9001, 13485 is now it's own stand-alone requirement. There is a possibility that 9001 and 13485 requirements may move farther apart as they evolve.