Contract Manufacturing

I have 8 years experience in cleaning and process validation, but never with contract manufacturing organizations (CMOs). What are the most critical issues to be aware of when overseeing validation activities at CMOs? Are there any industry guidance documents or regulations pertaining specifically to CMOs?


Validation is validation no matter if you do it yourself, your CM does it, or you hire a 3rd party to do it. And you are responsible for ensuring it’s done to whatever regulatory requirements exist, irrespective of the fact that the CM might be doing it. So you should definitely stay on top of the activities, ensuring they meet whatever requirements exist.

It’s a good idea to establish your requirements in either the contract or the quality agreement.

Thanks for the response. I was able to find some guidance for dealing with CMOs using the FDAs website.

In the Validation Template section in this site I posted vendor audit . I certainly hope it will be a great use to you.

Hi JulieC,

Good evening !

Great move from routine operations to contract mfg…

Well, while we are talking about contract mfg. Two major terms coming in thoughts…Contract Giver / Contract Acceptor & a relationship bond termed as Technical Quality Agreement.

All the concepts will remain same as for routine operations, however responsibility become based on “TQA”.
The criticality of validation is again depends up on the product you are going to be manufactured there & all relevent sections from technical package as transferred from Contract Giver should be evaluated during validation stage.

If you are looking ofr any specific query, please elaborate a littile bit more.

Happy Reading !

Guidance by APIC may become your cup of Tea, if looking for any specific Query !

Just browse the Link :