Good Manufacturing Practices for Pharmaceuticals Sixth Edition provides readers with fundamental knowledge of CGMP regulations and current industry applications and practices.

This Sixth Edition is significantly expanded to reflect the increase of information and changing practices in CGMP regulation and pharmaceutical manufacturing and control practices worldwide.

Good Manufacturing Practices for Pharmaceuticals Sixth Edition is an essential companion for every pharmaceutical professional

Each chapter has been updated and this book supplies new and must-have information regarding:

• the latest FDA guidance documents
• quality systems approach
• risk analysis and management
• quality by design
• standard operating procedures (SOPs), validation practices, and process analytical technology (PAT) initiatives
• contracting and outsourcing
• GMPs for Clinical Trial Materials
• active pharmaceutical ingredients (API) GMPs
• bulk pharmaceutical excipient GMPs and compliance
• equipment maintenance and calibration
• labeling regulations and applications
• failure investigations
• FDA enforcement tools
• inspection procedures, the pre-approval inspection process, and the Food and Drug Modernization Act
• worldwide GMP regulation
• ISO 9000 and Malcolm Baldrige approaches, and Six Sigma methodology

Contents

1. Status and Applicability of U.S. Regulations
2. Finished Pharmaceuticals General Provisions (Subpart A)
3. Organization and Personnel (Subpart B)
4. Buildings and Facilities (Subpart C)
5. Equipment (Subpart D)
6. Control of Components and Drug Product Containers and Closures (Subpart E)
7. Production and Process Controls (Subpart F)
8. Packaging and Labeling Control (Subpart G)
9. Holding and Distribution (Subpart H)
10. Laboratory Controls (Subpart I)
11. Records and Reports (Subpart J)
12. Returned and Salvaged Drug Products (Subpart K)
13. Repacking and Relabeling
14. Quality Systems and Risk Management Approaches
15. Clinical Trial Supplies and GMPs
16. Contracting and Outsourcing
17. Active Pharmaceutical Ingredients
18. Bulk Pharmaceutical Excipient GMPs
19. Recalls, Warning Letter, Seizures and Injunctions: CGMP Enforcement Alternatives in the United States
20. Controlled Substances Safeguards
21. The Inspection Procedure for Compliance in the United States: The Regulatee Is Inspected
22. The Rationale for Inspection
23. FDA Pre-Approval Inspections/Investigations: The Road from SUPAC to the Food and Drug Modernization Act
24. Worldwide GMPs
25. Quality Approaches: ISO 9000, Malcolm Baldrige and Six Sigma

Appendices

• Center for Drug Evaluation and Research (CDER) List of Guidance Documents
• ICH Guidelines
• FDA/ORA Compliance Policy Guides

Index

click here to see books of related interest

ORDER NOW Good Manufacturing Practices for Pharmaceuticals Sixth edition by Joseph D. Nally 2006 • 424 pages • $248.95 + shipping Texas residents please add 6.75 % sales tax