S-01. CGMP: Interpretation and Application

Course Description

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 revision, 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 focus on the FDA's current interpretation of the GMP regulation with an in-depth review of the agency's regulations, guidances, inspection guides, compliance policy guides, compliance programs, proposed rules, publications and policy statements. Each section of the GMP regulations is reviewed along with the FDA's interpretations of that section. An integral part of this course is the intensive class work to enhance the interpretation and practical application of the GMP requirements.

Learning Objectives

This course will provide the attendees with a practical understanding of the GMP regulations. They will be familiar with the available FDA documents and references that are essential for GMP interpretation, and the compliance and legal impact behind each of these references. The attendees will learn how to effectively use the FDA documents and references to provide an official interpretation of GMP requirements, and interpret and apply GMP regulations to specific operations and unique situations. This practical knowledge and understanding of the GMP regulations will provide the attendee with the skills to effectively communicate and negotiate with the FDA on GMP compliance issues.

Who Should Attend

This is an essential course for professionals who are responsible for GMP Compliance and Auditing, Quality Assurance and Regulatory Affairs. Production and support personnel, as well as those who need to interact with the FDA on GMP compliance issues, would benefit significantly from this course.

Course Outline

  • Review of GMP Regulations, FDA Publications and Other Sources of GMP Interpretations
  • Basic Techniques for GMP Interpretation
  • GMP Interpretation by Subpart with FDA References
    • GMP Preamble
    • FDA Guidances
    • ICH Guidelines (where applicable)
    • FDA Inspection Guides
    • FDA Compliance Programs
    • FDA Compliance Policy Guides
    • FDA Inspection Guides
    • Other FDA Publications; e.g. FDA cGMP notes
  • Review of FDA Inspectional Observations and Warning Letter Citations
  • Class Exercises on Practical Application and Interpretation of GMPs

Course Notes

The notes for this course will serve as a useful reference guide after the course. Each section of the GMP is reprinted in the course notes, followed by the interpretations for that section. Each interpretation includes the appropriate FDA reference. There is no similar reference publication available elsewhere.