Dietary Supplement Good Manufacturing Practices. Preparing for Compliance

Description

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.

The recent regulations, outlining broad goals, intentionally avoid specifics to allow for future technological advances—leaving implementation to the discretion of each firm. Given this latitude and flexibility, this new resource is an essential source of workable and practical suggestions on ways the industry can best meet the goals.

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 GMP 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

It covers:

• Personnel
• Plants and Grounds
• Equipment and Utensils
• Sanitation of Buildings and Equipment
• Quality Assurance and Laboratory
• Operations
• The Quality Control Unit
• Production and Process Controls

Contents

Preface
Introduction

1. The Basics of Good Manufacturing Practice
2. Adulteration and Contamination
3. Personnel Matters
4. Physical Plant and Grounds
5. Equipment and Utensils
6. Cleaning and Sanitation
7. Maintenance and GMP
8. Calibration
9. Requirement for Process Control Systems
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 Labelling Operations
18. Quality Control Responsibilities
19. Laboratory Operations
20. Returned Goods
21. Product Complaint Handling
22. Holding and Distributing
23. Recalls
24. Top Management Responsibilities
25. Record Keeping, Documentation, SOPs
26. Change Control
27. Adverse Event Reporting
28. Continuous Improvement
29. Supply Chain Management
30. Audits
31. Outsourcing
32. The FDA
33. FDA Inspections