GMPs for Pharmaceutical sterile production

Updated with the new EU Annex 1 – Manufacture of Sterile Medicinal Products (published 22 Aug 2022)

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Collection of the GMPs applicable to sterile 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 excipients
EU Guidelines for GMP, Annexes:
1 Manufacture of Sterile Medicinal Products
2 Manufacture of Biological active substances and Medicinal Products for Human Use
8 Sampling of Starting and Packaging Materials
11 Computerised Systems
13 Manufacture of Investigational Medicinal Products
15 Qualification and validation
16 Certification by a Qualified person and Batch Release
17 Parametric Release
19 Reference and Retention Samples
Glossary

Pages: 318
Language: English
Binding: Wire
Dim: 110×170 mm

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