Reply To: IP Related Docs

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Kathie Clark

Hi Brad,

I would appreciate the opinion of others, but I think that many of the document types you mention aren’t literally part of the TMF. For example, if you consult MHRA GCP, p. 333, there is a diagram that shows IMP documentation as part of “Supporting documentation” and not part of the TMF.

That doesn’t mean it’s not inspectable, but that the expectation would not be that it is filed in a TMF structure.

I also see the following in an MHRA presentation on GCP.
•Essential documents (E6 section 8) can reside on a single system, but the MHRA extended expectations include access to material residing on different systems:
–GMP data (e.g. batch records) not needed by clinical staff
–Regulatory documentation (e.g. applications to MHRA)

Would be interesting to hear from those with inspection experience on this point.