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EP general chapter-Extractable volume

  • 1.  EP general chapter-Extractable volume

    This message was posted by a user wishing to remain anonymous
    Posted 17-Mar-2023 16:20
    This message was posted by a user wishing to remain anonymous

    Dear community, I would like to have your insight regarding EP compliance in CTD dossier documents. When we document that a method has been performed according to EP, we are documenting that the method is according to EP. This means, the method has been executed as EP chapter indicates. I have a doubt regarding general method, Extractable volume. In this case, if the laboratory does not performed the test using the needle dimensions indicated in EP extractable volume general chapter, can still be consider that the method is EP compliant?

    Thank you in advance,