| Current Good Manufacturing Practices: Pharmaceutical, Biologics, and Medical Device Regulations and Guidance Documents Concise Reference Contributor(s): Allport-Settle, Mindy J. (Author) |
|
 |
ISBN: 1449505236 ISBN-13: 9781449505233 Publisher: Createspace Independent Publishing Platform OUR PRICE: $40.84 Product Type: Paperback - Other Formats Published: September 2009 |
| Additional Information |
| BISAC Categories: - Reference |
| Physical Information: 1.28" H x 5.98" W x 9.02" (1.84 lbs) 634 pages |
| Descriptions, Reviews, Etc. |
| Publisher Description: 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 |