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

by Mindy J. Allport-Settle

FDA Regulations and Associated Guidance - 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 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 General - Part 807 Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices - Part 820 Quality System Regulation Reference - Glossaries combined in one location - GMP Keyword Index for 21CFR211 - Combined Index for all documents

634 pages, Paperback

First published September 17, 2009