In a commercial process, can a non-conforming Intermediate be used if lab use tests show the drug substance is within specifications? Sometimes, even in production, you set the specs for Intermediates. Sometimes the Intermediate batch did not meet the specs for Intermediates. But then you do another few tests, and the drug substance derived from that batch looks good. It passes all the specifications for the drug substance. Can you consider that compliant to a GMP or is it not?
Under GMPs, deviations can be justified and things can go ahead. There may be filing issues, if you’re outside of a filing or a registration. But, in terms of GMPs, there’s nothing inherently wrong.
