Current Good Manufacturing Practices: Pharmaceutical, Biologics, and Medical Device Regulations and Guidance Documents Concise Reference

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FDA Regulations and Associated Guidance Documents: – Part 11 Electronic Records; Electronic Signatures – Part 26 Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports: United States and the European Community – Part 200 Drugs General – Part 207 Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution – Part 210 Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs – Part 211 Current Good Manufacturing Practice For Finished Pharmaceuticals – Part 600 Biological Products: General – Part 807 Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices – Part 820 Quality System Regulation Reference Tools: – Glossaries combined in one location – GMP Keyword Index for 21CFR211 – Combined Index for all documentsCurrent Good Manufacturing Practices Pharmaceutical Biologics and Medical Device Regulations and Guidance Documents Concise Reference

Good Manufacturing Practices for Pharmaceuticals