deviation from Pharmacopiea spec's

2 posts / 0 new
Last post
Rajiv Dua
Rajiv Dua's picture
deviation from Pharmacopiea spec's

Ques- We are a biosimilar company. Can we deviate from the specifications given in pharmacopoeia and if yes, how much deviation is allowed?

GMP Docs
GMP Docs's picture
It all depends on your own QA

It all depends on your own QA policies and specifications.  If you need a Deviation Report SOP, check out this document at GMPDocs.com.