FDA cGMP: Interpretation and Application (Dietary Supplements)

Dietary supplement GMP requirements, as specified in 21CFR Part 111, are general and subject to interpretation.

FDA issued a final rule regarding current good manufacturing practice (cGMP) for dietary supplements on June 25th, 2007 and it was effective in September, 2007. The rule has a staggered three-year phase-in for compliance. Large companies have until June 2008 before FDA will conduct GMP audits; companies with less than 500 employees have until June 2009; and companies with fewer than 20 employees have until June 2010 to comply with the regulations. Thus, small businesses have three years before FDA will conduct GMP Audits.

This course will concentrate on the FDA's current interpretation of the GMPs with an in-depth review of the agency's regulations, preamble, guidelines, inspection guides, compliance programs, publications and policy statements. Each section of the GMP regulations will be reviewed along with the FDA's interpretation of that section. An integral part of this course will include discussions on the FDA's interpretation and application of current GMP with a review of pertinent inspectional observations (FDA-483) and warning letters.

• Review of GMP Regulation with Reference Materials
• History of Dietary Supplement GMP Regulations
• 21 CFR Part 111 – Current Good Manufacturing Practices for Dietary Supplements
  • Subpart A: General provisions
  • Subpart B: Personnel
  • Subpart C: Physical plant and grounds
  • Subpart D: Equipment and utensils
  • Subpart E: Requirement to establish a production and process control system
  • Subpart F: Requirements for quality control
  • Subpart G: Requirements for components, packaging, and labels and for product that you receive for packaging or labeling as a dietary supplement
  • Subpart H: Requirements for themaster manufacturing record
  • Subpart I: Requirements for the batch production record
  • Subpart J: Requirements for laboratory operations
  • Subpart K: Requirements for manufacturing operation
  • Subpart L: Requirements for packaging and labeling operations
  • Subpart M: Holding and distributing
  • Subpart N: Returned dietary supplements
  • Subpart O: Product complaints
  • Subpart P: Records and recordkeeping
• Review of FDA Inspectional Observations
• Class Exercises on Practical Application and Interpretation of GMPs