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CFSAN/Office of Nutrition, Labeling and Dietary Supplements
October 24, 2007

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

[Presenter's Script]

Begin Presentation in HTML format or as a PowerPoint presentation

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

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 

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Hypertext updated by shm January 31, 2008