Good manufacturing practices for pharmaceuticals
| Main Author: | |
|---|---|
| Format: | Book |
| Language: | English |
| Published: |
New York, NY :
Informa Healthcare ,
c2010
|
| Edition: | 6th ed. |
| Series: | Drugs and the pharmaceutical sciences
v.169 |
| Subjects: |
Table of Contents:
- 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.