GMPs for Pharmaceutical production/API

Collection of the GMPs:
21 CFR Part 210 Current Good Manufacturing Practice in Manufacturing, Processing, Packing or Holding of Drugs; General
21 CFR Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals
21 CFR Part 11: Electronic Records; Electronic Signatures
EU Guidelines for GMP, Part I: Medicinal Products for Human and Veterinary Use
EU Guidelines for GMP, Part II: Basic Requirements for Active Substances used as Starting Materials
EU Guidelines for Excipients
EU Guidelines on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for
human use

– Pocket size, 95 x 155 mm
– Wire binding for ease-of-use

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