Good manufacturing practices for pharmaceuticals - Nally, Joseph D. (New York, NY : Informa Healthcare, 2010)
1. Status and Applicability of U.S. Regulations: Current Good Manufacturing Practices in Manufacturing, Processing, Packaging, and Holding of Drugs -- 2. Finished Pharmaceuticals: General Provisions -- 3. Organization and Personnel -- 4. Buildings and Facilities -- 5. Equipment -- 6. Control of Components and Drug Product Containers and Closures -- 7. Production and Process Controls -- 8. Packaging and Labeling Contro -- 9. Holding Distribution -- 10. Laboratory Controls -- 11. Records and Reports -- 12. Returned and Salvaged Drug Products -- 13. Repacking and Relabeling -- 14. Quality Systems and Risk Management Approaches -- 15. Clinical Trial Supplies and Current Good Manufacturing -- 16. Contracting and Outsourcing -- 17. Active Pharmaceutical Ingredients -- 18. Bulk Pharmaceutical Excipient GMPs -- 19. Recalls, Warning Letters, Seizures and Injunctions: CGMP Enforcement Alternatives in the United States -- 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) -- 22. FDA Pre-Approval Inspections/Investigations: The Road from Scale-Up and Post-Approval Changes in the Food and Drug Modernization Act -- 23. World-Wide Good Manufacturings Practices -- 24. Quality Approaches: ISO 9000, Malcolm Baldrige, and Six Sigma -- Appendix A: Center for Drug Evaluation and Research: List of Guidance Documents -- Appendix B: ICH Guidelines -- Appendix C: Food and Drug Administration (FDA) Office Regulatory Affairs (ORA) Compliance Policy Guides -- Index.
Includes bibliographical references and index
Keywords: Drug Industry -- Standard; Drugs -- Standards -- United States; Legislation, Drug; Pharmaceutical industry -- Quality control; Pharmaceutical Preparations -- Standard