EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use

Published by European Commission (EC)ECRIN

Clinical Trials Toolkit

Good manufacturing practice (GMP) describes the minimum standard that a medicines manufacturer must meet in their production processes. The European Medicines Agency (EMA) coordinates inspections to verify compliance with these standards and plays a key role in harmonising GMP activities at European Union (EU) level. The Annex also includes guidance on ordering, shipping, and returning clinical supplies, which are at the interface with, and complementary to, guidelines on Good Clinical Practice.

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