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GMP Fundamentals
A Step-by-Step Guide


A practical and easy to read guideline, giving you a quick and comprehensive overview of the complex world of Good Manufacturing Practice (GMP).



Question of the Week

Are there exceptions from the requirement of a written confirmation?

The Commission publishes a list of countries which, following their request, have been assessed and are considered as having equivalent rules for good manufacturing practices to those in the EU. Active substances manufactured in these countries do not require a written confirmation.

[GMP MANUAL Chapter C.8.5.1 Importation of Active Substances for Medicinal Products for Human Use Questions and Answers]

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