Establishing A CGMP Laboratory Audit System: A Practical GuideJohn Wiley & Sons, 28 Apr 2006 - 304 halaman The first systematic, hands-on auditing guide for today's pharmaceutical laboratories In today's litigious environment, pharmaceutical laboratories are subject to ever stricter operational guidelines as mandated by the FDA, and must be able to establish and demonstrate sustainable operational practices that ensure compliance with the current good manufacturing practice (CGMP) regulations. David Bliesner's Establishing a CGMP Laboratory Audit System: A Practical Guide is designed to provide laboratory supervisors and personnel with a step-by-step, hands-on audit system that they can rely on to ensure their facility remains compliant with all current and future requirements. Focusing on a "team approach," the author uses detailed flowcharts, checklists, and descriptions of the auditing process to help readers develop a new audit system or upgrade their current system in order to: * Improve current compliance * Demonstrate sustainable compliance * Produce data for federal inspections * Avoid regulatory action Enhanced with detailed checklists and a wealth of practical and flexible auditing tools on CD-ROM, this book provides an ideal resource for new and future laboratory personnel, and an excellent means for keeping existing industry practitioners up to date on the nuances of operating a consistently compliant pharmaceutical laboratory. |
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3 AUDITING AND DATA CAPTURE | 27 |
4 ORGANIZING DATA AND REPORTING THE RESULTS | 45 |
5 DEVELOPING AND IMPLEMENTING A CORRECTIVE ACTION PLAN | 53 |
6 DEVELOPING AND IMPLEMENTING A VERIFICATION PLAN | 69 |
7 DEVELOPING AND IMPLEMENTING A MONITORING PLAN | 84 |
8 A SUMMARY FOR ESTABLISHING A CGMP LABORATORY AUDIT SYSTEM | 89 |
APPENDIX I EXAMPLE AUDIT CHECKLISTS LABORATORY SUBELEMENTS | 94 |
APPENDIX II EXAMPLE TEMPLATE FOR AN AUDIT SUMMARY REPORT | 146 |
APPENDIX III GLOSSARY OF CGMP AND AUDIT SYSTEM TERMS | 200 |
APPENDIX IV FDA COMPLIANCE PROGRAM GUIDANCE MANUAL 7356002 DRUG MANUFACTURING INSPECTIONS | 215 |
APPENDIX V 21 CODE OF US FEDERAL REGULATIONS PARTS 210 AND 211 CURRENT GOOD MANUFACTURING PRACTICE REGULAT... | 236 |
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Edisi yang lain - Lihat semua
Establishing A CGMP Laboratory Audit System: A Practical Guide David M. Bliesner Pratinjau tidak tersedia - 2006 |
Establishing A CGMP Laboratory Audit System: A Practical Guide David M. Bliesner Pratinjau tidak tersedia - 2006 |
Establishing A CGMP Laboratory Audit System: A Practical Guide David M. Bliesner Pratinjau tidak tersedia - 2006 |
Istilah dan frasa umum
action owners action project plan Administrative Systems appropriate approved assure audit checklist audit summary report audit team leader batch batch production Blistex breakdown structure Checklist Continued closures complete compliance with CGMPs components corrective action team corrective and preventive coverage CPGM Current Practice defined determine drug product containers evaluation excipients facilities findings functional area managers HPLC identified implemented in-process materials Inspection Option Laboratory Computer Systems Laboratory Control System Laboratory Documentation Practices Laboratory Equipment Qualification Laboratory Investigations Laboratory Managerial Managerial and Administrative manufacturing practice methods validation monitoring packaging and labeling penicillin performed phase Potential Corrective Action Potential Root Cause Practices and Standard preventive actions quality control unit Quality Operations Laboratory Quality System records requirements responsibilities schedule specifications statistical sampling Step Yes storage Subpart system deficiencies tamper-evident Technology Transfer testing Validation and Technology verification report verification team leader workflow written procedures