Good Clinical Practice Guide
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Thread: IMPs and same/different batch

  1. #1

    IMPs and same/different batch

    Should the investigational medicinal products used in a clinical trial be always from a single batch?

    Can reference drug from different batches of the same MAH and manufacturer be used in a clinical trial? If yes, what additional documentation(s) need to be provided in this scenario?

  2. #2
    Forum Member
    Join Date
    Nov 2011
    Would be good to check with GMP. The BARQA GMP website offers a Q & A section. I suspect that it is not a requirement to use a single batch. but It would be necessary to submit a CofA for each batch.

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