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Presentation: Implementation of FDA's Current Good Manufacturing Practices for Dietary Supplements

October 24, 2007

Author: Angela Pope, MBA, FDA Center for Food Safety and Applied Nutrition

[Presenter's Script]

Also available as a PowerPoint Presentation

Table of Contents
  1. Implementation of FDA's Current Good Manufacturing Practices for Dietary Supplements
  2. Current Good Manufacturing Practices (CGMP's) for Dietary Supplements
  3. CGMP's
  4. CGMP's
  5. Who is Subject to this Part? §111.1
  6. Definitions §111.3
  7. Other Statutory Provisions and Regulations? §111.5
  8. CGMP's
  9. Personnel Subpart B
  10. CGMP's
  11. Physical Plant and Grounds Subpart C
  12. CGMP's
  13. Equipment and Utensils Subpart D
  14. CGMP's
  15. Production and Process Controls Subpart E
  16. Production and Process Controls Subpart E
  17. Production and Process Controls Subpart E
  18. CGMP's
  19. Controls Requirements for Quality Control Subpart F
  20. Controls Requirements for Quality Control Subpart F
  21. Controls Requirements for Quality Control Subpart F
  22. CGMP's
  23. Requirements for Components, Packaging, Labeling Subpart G
  24. CGMP's
  25. Master Manufacturing Record Subpart H
  26. CGMP's
  27. Batch Production Record
  28. CGMP's
  29. Requirements for Laboratory Operations
  30. CGMP's
  31. Manufacturing Operations
  32. CGMP's
  33. Requirements for Packaging and Labeling Operations
  34. Requirements for Packaging and Labeling Operations
  35. CGMP's
  36. Holding and Distributing
  37. CGMP's
  38. Returned Dietary Supplements
  39. Returned Dietary Supplements
  40. CGMP's
  41. Product Complaints
  42. CGMP's
  43. Records and Recordkeeping
  44. Petition to Request Exemption from 100 Percent Identity Testing of Dietary Ingredients Interim Final Rule (IFR) 72 FR 34959 June 25, 2007
  1. IFR
  2. IFR
  3. IFR
  4. IFR
  5. IFR
  6. IFR
  7. IFR
  8. IFR
  9. IFR
  10. IFR
  11. IFR
  12. IFR
  13. IFR
  14. IFR
  15. IFR
  16. IFR
  17. Current DSGMP's
  18. General Provisions
  19. Personnel
  20. Physical Plant & Grounds
  21. Physical Plant & Grounds
  22. Equipment and Utensils
  23. Production and Process Control
  24. Current DSGMP's
  25. Monika Samtani Moderator
  26. Janice Oliver Deputy Director, CFSAN
  27. Vasilios H. Frankos, Ph.D. Dir., Division of Dietary Supplements CFSAN
  28. Brad Williams Special Asst. to Division Director Division of Dietary Supplements CFSAN
  29. Sara Dent Acosta, MS, MPH Consumer Safety Officer LOS-DO, FDA
  30. Implementation of Current Good Manufacturing Practices for Dietary Supplements
  31. Sub Parts A - C
  32. Sub Parts D - P
  33. Interim Final Rule
  34. Inspections and Other Considerations
  35. Moderator
  36. Panelists/Presenters
  37. Writer
  38. Technical Assistance
  39. In case of Trouble
  40. Phone Bridge
  41. Produced at the FDA TV Studios, Division of Communication Media
  42. Cameras
  43. Videotape
  44. Engineering Services

An archived webcast of the Satellite Broadcast is available online (2:58:55 hours). Exit Disclaimer
Note: Internet Explorer is required to view the closed captions.

    
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