1. Status and applicability of U.S. regulations : current good manufacturing practices in manufacturing, processing, packaging, and holding of drugs / Joseph D. Nally -- 2. Finished pharmaceuticals : general provisions, subpart A / Joseph D. Nally -- 3. Organization and personnel, subpart B / Joanne W. Cochran and Joseph D. Nally -- 4. Buildings and facilities, subpart C / Robert Del Ciello -- 5. Equipment, subpart D / Robert Del Ciello, Joseph T. Busfield, and Steven Ostrove -- 6. Control of components and drug product containers and closures, subpart E / Arlyn R. Sibille -- 7. Production and process controls, subpart F / Joseph D. Nally and Michael D. Karaim -- 8. Packaging and labeling control, subpart G / Arlyn R. Sibille -- 9. Holding distribution, subpart H / Joseph D. Nally -- 10. Laboratory controls, subpart I / Wayne J. DeWitte and Lex M. Hoinowski -- 11. Records and reports, subpart J / Arlyn R. Sibille ... [et al.] -- 12. Returned and salvaged drug products, subpart K / Joseph D. Nally -- 13. Repacking and relabeling / Joseph D. Nally -- 14. Quality systems and risk management approaches / Joseph D. Nally and Laura L. Nally -- 15. Clinical trial supplies and current good manufacturing / Graham Bunn -- 16. Contracting and outsourcing / Graham Bunn -- 17. Active pharmaceutical ingredients / P. Denis Celentano -- 18. Bulk pharmaceutical excipient GMPs / Irwin Silverstein -- 19. Recalls, warning letters, seizures and injunctions : CGMP enforcement alternatives in the United States / Joseph D. Nally -- 20. Control substances safeguards (21 CFR 1300, et seq.) / Joseph D. Nally -- 21. The inspection procedures for compliance in the United States : the regulatee is inspected; the rational for inspection (21 USC 373, 374) / Joseph D. Nally -- 22. FDA pre-approval inspections/investigations : the road from scale-up and post-approval changes in the food and drug modernization act / Joseph D. Nally -- 23. World-wide good manufacturings practices / Joseph D. Nally -- 24. Quality approaches : ISO 9000, Malcolm Baldrige, and Six Sigma / Joseph D. Nally.