US and EU GMP’s for Pharmaceuticals, EPUB

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SKU : 1369en Categories : ,
Language : English
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Collection of US and EU GMP’s for Pharmaceutical Production:
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 GMP, Part III – Guidelines on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use

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