FDA cGMP: Interpretation and Application (Drug Products)

Pharmaceutical GMP requirements, as specified in 21CFR211, are general and subject to interpretation. The FDA stated that the GMP was intentionally written as such to allow the pharmaceutical industry the flexibility to apply the GMP in a manner appropriate for each specific operation. To keep pace with the rapid technological advances in the industry since the 1978 GMP revisions, the FDA has been supplementing the GMP with interpretive guides, guidelines and policy statements to keep it current and to ensure its applicability to current industry operations and practices.

This course will concentrate on the FDA's current interpretation of the GMPs with an in-depth review of the agency's regulations, guidelines, inspection guides, compliance policy guides, compliance programs, proposed rules, 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).

• Review of GMP Regulations, FDA Publications and Advisory Opinions
• Basic Techniques for GMP Interpretation
• GMP Interpretation by Subpart with FDA References
  • GMP Preamble
  • FDA Guidelines
  • FDA Inspection Guides
  • FDA Compliance Programs
  • FDA Compliance Policy Guides
  • FDA Policy Statements
  • Other FDA Publications
• Review of FDA Inspectional Observations
• Class Exercises on Practical Application and Interpretation of GMPs