Good Manufacturing Practices for Pharmaceuticals, Seventh Edition (Paperback, 7 ed)

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