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  • Hi James,  Should we expect to see more detail posted on this forum or in some other area? Looking forward to your follow-up. Thanks,  Sean ------------------------------ Sean Harrison White Plains NY United States ------------------------------

  • I forgot that I could add a file to a response, so I've attached the GHTF guidance document I mentioned.   Remember that MDSAP does not add any requirements. Instead, provides a coordinated framework to audit the requirements that already exist. ------------------------------ Dan O'Leary Swanzey NH United States ---------------------------- ...

  • I believe the answer to your question 'I am a FP manufacturer located outside EU. So, Can I release my batch from my manufacturing site but batch release will not happen from EU batch release site until variation approval. Is that possible? " is Yes.  However, the responsibility for EU batch release falls to the QP and MA holder, rather than the FP ...

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