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EMA clarifies GMP guide

This article was originally published in The Gold Sheet

Executive Summary

The European Medicines Agency says that as part of its efforts to clarify how certain parts of the EU GMP guide should be interpreted by competent authorities and manufacturers, it periodically issues a questions-and-answers guide. These questions actually come up at EMA Inspectors' Working Group meetings. The latest version addresses questions related to the guide's Part 1 on basic requirements for medicinal products, Part II on basic requirements for active substances used as starting materials as well as questions related to EU GMP guide annexes. It addresses whether audits performed by third parties are acceptable and how GMP compliance for active substance manufacturers can be demonstrated
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