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

Autor Mindy J. Allport-Settle
en Limba Engleză Paperback – 31 aug 2009
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 documents
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Specificații

ISBN-13: 9781449505233
ISBN-10: 1449505236
Pagini: 634
Dimensiuni: 152 x 229 x 33 mm
Greutate: 0.84 kg
Editura: CREATESPACE