Industry API Guidance Says How to Ensure Starting Materials Are GMP Compliant

Executive Summary Guidance from a European chemical industry group's API committee could help pharmaceutical manufacturers ensure that suppliers are applying GMP controls early enough in the active pharmaceutical ingredient manufacturing process, industry official tells ISPE meeting. While ICH Q7 guidance explains what to do when applying GMPs to...

Executive Summary

Guidance from a European chemical industry group's API committee could help pharmaceutical manufacturers ensure that suppliers are applying GMP controls early enough in the active pharmaceutical ingredient manufacturing process, industry official tells ISPE meeting. While ICH Q7 guidance explains what to do when applying GMPs to APIs, the committee's document fills in some of the details on how to do it.

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Source: pink.pharmaintelligence.informa.com