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Dietary supplement good manufacturing practices preparing for compliance

Mead, William J.

Dietary supplement good manufacturing practices preparing for compliance

Mead, William J.

9781420077414

New York : Informa Healthcare, 2012.

xiv, 298 p.

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, and SOPs -- 26. Change control -- 27. Adverse event reporting and record keeping -- 28. Adulteration and contamination -- 29. Supply chain integrity -- 30. Audits -- 31. Outsourcing -- 32. The Food and Drug Administration -- 33. FDA inspections.

"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 advancesleaving 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 controlsuggestions and practical recommendations on "how-to" achieve full complianceexplanation of the FDAs role regarding inspection, enforcement, recall/seizure of products and prosecutionDietary Supplement Good Manufacturing Practices (GMP) covers:PersonnelPlants and Grounds Equipment and UtensilsSanitation of Buildings and EquipmentQuality Assurance and Laboratory OperationsThe Quality Control UnitProduction and Process Controls"-- Provided by publisher.

Dietary supplements -- Standards.

Dietary supplements industry -- Standards.

Manufacturing processes -- Standards.

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