CFR 210 & CFR 211 - Major Differences to EU GMP (Good Manufacturing Practices)

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nicnac88

I'm not sure if there has already been a thread for this & from what I have seen a few people have asked this question but haven't received much of a reply but I said I'd give it a shot anyways! I'm currently putting together a presentation intended to move our company from the EU pharmaceutical market into the US market & from studying CFR 210 & 211 I am finding it very hard to note major differences in the GMP requirements. If anybody has previously worked on the differences or could point me in the right direction I would be extremely grateful.

Thanks!
 

Stijloor

Leader
Super Moderator
Re: CFR 210 & 211 major differences to EU GMP

Any GMP experts who can help?

Thank you!!

Stijloor.
 
P

peter chan

John Sharp had written a book name "Good Pharmaceutical Manufacturing Practice- Rationale and Compliance". He compared both US GMP and EU GMP section by section. You may check it out.
 
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