GMP Publications - Code of Federal Regulation Handbooks by the FDA

EU GMPs with Annex 1 Sterile Medicinal Products

EU GMPs W/Annex 1

European Union

The EU GMPs include Chapters 1-9 - EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary.

European Union (EU) Annexes

Annex 1 Sterile Medicinal Products guidance. Annex 1 of the EC Guide to Good Manufacturing Practice (GMP) provides supplementary guidance on the application of the principles and guidelines of GMP to sterile medicinal products. The guidance includes recommendations on standards of environmental cleanliness for clean rooms.

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