21 CFR Parts 210/211 with EU Annex 1

The GMP 210/211 regulations address issues including recordkeeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling.

Annex 1 - 2023 -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.

This is a great training and information tool to provide all employees with the CFR requirements for Drug, and Combination Products supporting OTC and Ethical manufacturing.

They fit neatly into your pocket. (size 3.75" x 6.25")

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