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deviation from Pharmacopiea spec's

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Rajiv Dua
India

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Topic Started by Rajiv Dua
on 4/12/2010 0:19 AM   
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Ques- We are a biosimilar company. Can we deviate from the specifications given in pharmacopoeia and if yes, how much deviation is allowed?

Learning is a treasure that will follow its owner everywhere.....RD
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GMPDocs
United States

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Posted By GMPDocs
on 1/27/2011 10:45 AM   
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It all depends on your own QA policies and specifications.  If you need a Deviation Report SOP, check out this document at GMPDocs.com.
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