GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, (Volume 2 - Regulations, Standards, and Guidelines): Regulations, Standards, and GuidelinesCRC Press, 30 Des 2004 - 452 halaman This well-known QA manual has been updated to provide the guidance readers need to assess their compliance with standard regulations. This Volume 2 of a three-part package contains the full text on: * FDA regulations* EC and IPEC guidelines* ISO/BSI standards referenced in the checklists furnished in volume 1Easy-to-read and organized to provide fa |
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Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals | 31 |
Part 1301 Registration of Manufacturers Distributors and Dispensers of Controlled Substances | 99 |
Part 1302 Labeling and Packaging Requirements for Controlled Substances | 135 |
MILSTD790F | 201 |
Good Manufacturing Practices Medicinal Products for Human and Veterinary Use | 221 |
Quality Management and Quality Assurance Standare Part 3 | 279 |
INTERNATIONAL STANDARD ISO 9001 | 315 |
INTERNATIONAL STANDARD ISO 9001 | 331 |
Quality Systems Medical Devices Particular Requirements for the Application of ISO 9001 | 359 |
Quality Systems Medical Devices Particular Requirements for the Application of ISO 9002 | 371 |
General Requirements for the Competence of Testing and Calibration Laboratories | 383 |
Part 1303 Quotas | 139 |
Part 1304 Records and Reports of Registrants | 149 |
Part 1305 Order Forms | 165 |
Part 1306 Prescriptions | 173 |
Part 1307 Miscellaneous | 185 |
MILQ9858A | 189 |
1994 and ISO 90021994 | 412 |
Annex B Informative Guidelines for Establishing Applications for Specific Fields | 414 |
INTERNATIONAL STANDARD ISO 19011 | 417 |
IPEC GMP for Bulk Excipients | 447 |
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GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their ... Leonard Steinborn Pratinjau tidak tersedia - 2004 |
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acceptance accordance action activities additional Administrator analysis and/or application appropriate approved areas assurance audit authorized batch calibration carried changes chapter cleaning complete components conducted conformance containers contract controlled substances corrective criteria defined described determine dispensed distribution documented drug product effective electronic ensure equipment established evaluation facilities given guidance handling hearing identified implementation import individual inspection instructions intended intermediate International Standard issued labeling laboratory limits listed maintain maintenance management system manufacturer materials measurement medical devices meet methods monitoring necessary nonconforming NOTE objectives operations organization packaging performed person personnel practice prepared prescription prevent procedures purchased pursuant quality system quantity records reference registration release requirements responsibility sampling Schedule Section specifications storage suitable supplier taken technical units validation verify written