GMPs for APIs : Interpretation of the ICH Q7 Guide

This document was written by experts from the European Industry (CEFIC APIC). It is essentially an interpretation of “how to” implement the ICH Q7 Guide based on practical experience. Other relevant publications (e.g. ISPE Baseline Guides, other ICH Guidelines) were considered and references included.
This document does not intend to provide an exhaustive list of “how to” comply with the above-mentioned requirements and recommendations. It does however provide examples of commonly applied solutions and practical assistance on how require-ments and recommendations can be met and /or interpreted.


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