GMP for APIs
ICH Q7 combined with APIC/Cefic ''How to do'' Document
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Beschreibung
The ICH Q7 is the most important GMP guideline for active pharmaceutical ingredients manufacturers worldwide.
As an interpretation aid the CEFIC/APIC published a “How to do” Document. This document, developed by experts of the European industry, describes generally accepted solutions, helps to interpret recommendations and shows how to approach the implementation of requirements.
We have editorially combined the recently updated text of the “How to do” Document (August 2012) with the ICH Q7 Guideline, to provide you with a valuable interpretation tool directly related to the regulatory text.
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