Description
Taylor & Francis Ltd Good Manufacturing Practices for Pharmaceuticals 7th Edition 2021 by Graham P. Bunn
This book provides insight into the world of pharmaceutical quality systems and the key elements that must be in place to change the business and organizational dynamics from task-oriented procedure-based cultures to truly integrated quality business systems that are self-detecting and correcting. Chapter flow has been changed to adopt a quality systems organization approach, and supporting chapters have been updated based on current hot topics including the impact of the worldwide supply chain complexity and current regulatory trends.Key Features:Presents insight into the world of pharmaceutical quality systemsAnalyzes regulatory trends and expectationsIncludes approaches and practices used in the industry to comply with regulatory requirementsDiscusses recent worldwide supply chain issuesDelivers valuable information to a worldwide audience regarding the current GMP practices in the industry
Table of contents : PrefaceEditorContributors1. Status and Applicability of U.S. Regulations: CGMPGraham P. Bunn2. Quality Management Systems and Risk ManagementJoseph C. Near3. Management Responsibility and ControlJohn E. Snyder4. Organization and PersonnelGraham P. Bunn and Joanna B. Gallant5. Finished Pharmaceuticals: General ProvisionsGraham P. Bunn6. Production and Process ControlsJocelyn A. Zephrani7. Records and ReportsGraham P. Bunn8. Clinical Trial SuppliesDavid Stephon9. Contracting and OutsourcingJoseph C. Near10. Buildings and FacilitiesRobert Del Ciello11. EquipmentRobert Del Ciello and Joseph T. Busfield12. Control of Components and Drug Product Containers and ClosuresGraham P. Bunn13. Holding and DistributionAndrew Acker14. Returned and Salvaged Drug ProductsGraham P. Bunn15. Active Pharmaceutical IngredientsJoseph C. Near16. Pharmaceutical Excipient Good Manufacturing PracticesIrwin Silverstein17. Packaging and Labeling ControlGraham P. Bunn18. Laboratory ControlsAlex M. Hoinowski19. Microbiological Aspects of Pharmaceutical Aseptic Processing in the Compounding PharmacyDawn McIver20. CGMP Enforcement Alternatives in the United StatesDaniel G. Jarcho and Cathy L. Burgess21. FDA Inspection ProcessCathy L. Burgess and Daniel G. Jarcho22. FDA Pre-approval InspectionsCathy L. Burgess, Justin Mann, and Seth Olson23. Worldwide Good Manufacturing PracticesDominic Parry24. Data Integrity and Fundamental ResponsibilitiesRandy Hightower and Michele PruettIndex