Dietary Supplement GMP is a one-stop "how-to" road map to the final dietary supplement GMP regulations recently issued by the FDA covering the manufacture, packaging and holding of dietary supplement products.

Based on broad experience with GMP compliance techniques worked out over the years in the food, drug, and medical device industries, it is a must-have guide for all DS companies, especially the many smaller firms for whom this is new territory.

Dietary Supplement Good Manufacturing Practices provides:

• a practical guide in easy to understand language to help navigate through the requirements for systems covering process and quality control
• suggestions and practical recommendations on "how-to" achieve full compliance
• explanation of the FDA’s role regarding inspection, enforcement, recall/seizure of products and prosecution

Contents

1. The Basics of Good Manufacturing Practice
2. Regulatory Overview
3. Personnel Matters
4. Physical Plant and Grounds
5. Equipment and Utensils
6. Cleaning and Sanitation
7. Maintenance and GMP
8. Calibration
9. Production and Process Controls
10. Specifications
11. Sampling
12. Deviations and Corrective Actions
13. Incoming Components, Packaging Materials and Labels
14. Master Manufacturing Record
15. Batch Production Record
16. Manufacturing Operations
17. Packaging and Labeling Operations
18. Quality Control Responsibilities
19. Laboratory Operations
20. Returned Goods
21. Product Complaint Handling
22. Holding and Distributing
23. Handling Recalls
24. Top Management Responsibility
25. Record Keeping, Documentation, SOPs
26. Change Control
27. Adverse Event Reporting and Records Keeping
28. Continuous Improvement
29. Supply Chain Integrity
30. Audits
31. Outsourcing
32. The FDA
33. FDA Inspectors

Index

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