Reply To: IP Related Docs

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Christine Evans

Hello all, i know this topic was addressed quite some time ago, but i would like something definitive related to the topic of IP/Supply documents, GMP documents.

My understanding is by using the TMF reference model, documents listed in section 06 are required if so stated, by trial/county/site level. Is this the complete “list” of what GMP documents are required to be in tmf?

Can GMP documents that are not noted on the TMF reference model be filed in Veeva Quality Docs and is that acceptable for an inspection? Should they be filed on SharePoint? What guidance are other sponsors following for GMP documentation/filing?

I do apologize for any redundancy of this topic but i admit i need further clarity to provide to my team.