Implementation of FDA’s Current Good Manufacturing Practices for Dietary Supplements. Current Good Manufacturing Practices (CGMP’s) for Dietary Supplements.
Implementation of FDA’s Current Good Manufacturing Practices for Dietary Supplements
This final rule establishes the minimum CGMP’s to manufacturing, packing, labeling, or holding dietary supplements to ensure the quality of the dietary supplement.
The final rule is organized into 16 subparts that focus on specific aspects of the manufacturing process or addressing specific issues.
Package, label or distribute manufactured by another firm.
Sell in bulk to a distributor
Imported or offered for importWho is Subject to this Part?§111.1
In addition to these regulations, you must comply with other applicable statutory provisions and regulations related to dietary supplements.
Physical Plant and Grounds
Equipment and Utensils
Production and Process Controls
Control Requirements for Quality Control
Requirements for Components, Packaging and Labeling
Master Manufacturing Record
Batch Production Record
Batch Laboratory Operations
Requirements for Packaging and Labeling Operations
Holding and Distributing
Returned Dietary Supplement
Record and Recordkeeping
Ref: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplements
FDA will consider, on a case-by-case basis, a manufacturer’s conclusion, supported by appropriate data and information in the petition submission, that it has developed a system that it would implement as a sound, consistent means of establishing, with no material diminution of assurance compared to the assurance provided by 100 percent identity testing, the identity of the dietary ingredient before use.
Inspections of Dietary Supplement firms:
There are a variety of firms of different sizes and performing different activities that will be subject to the new regulations.
Monika Samtani Testing of Dietary Ingredients
Janice Oliver Testing of Dietary Ingredients
Deputy Director, CFSAN
Vasilios H. Frankos, Ph.D. Testing of Dietary Ingredients
Dir., Division of Dietary Supplements
Brad Williams Testing of Dietary Ingredients
Special Asst. to Division Director
Division of Dietary Supplements
Sara Dent Acosta, MS, MPH Testing of Dietary Ingredients
Consumer Safety Officer
Implementation of Current Good Manufacturing Practices for Dietary Supplements
Sub Parts A - C Dietary Supplements
Sub Parts D - P Dietary Supplements
Interim Final Rule Dietary Supplements
Inspections and Dietary Supplements
Moderator: Dietary Supplements
Panelists/Presenters: Dietary Supplements
Dr. Vasilios Frankos
Sara Dent Acosta
Writer: Dietary Supplements
Angela Pope, MBA
Consumer Safety Officer
Technical Assistance: Dietary Supplements
Dr. Robert Moore, PhD
Dr. Kenneth Taylor, PhD
In case of Trouble: Dietary Supplements
Check with your IT department.
If unsuccessful, call:
Phone Bridge: Dietary Supplements
Produced at the Dietary Supplements
FDA TV Studios, Division of Communication Media
Barbara Ann Richards
Cameras Dietary Supplements
Videotape Dietary Supplements
Engineering Services Dietary Supplements
Contract Video Specialists
Dr. Robert McCleary