CGMP: Interpretation and Application

Industry field:

Pharmaceutical industry, Final dosage form

Course description:

The pharmaceutical GMP regulations in 21CRF211 are written in a very general format and, therefore, must be interpreted to ensure their proper and effective application. The FDA stated that the GMP was intentionally written as such to allow the pharmaceutical industry flexibility to apply the GMP in a manner appropriate for each specific operation and pharmaceutical product. To keep pace with the rapid technological advances in the industry since the 1978 GMP rewrite, the FDA has been supplementing the GMP regulations with interpretive guides, guidelines, policy statements, and revisions to keep the regulations current, and to ensure their applicability to current industry operations and practices.

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

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

      - 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

Learning objectives:

This course will provide the attendees with a practical understanding of the GMP regulations. They will become 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 and most precise interpretation of each GMP requirement, and interpret and apply the 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 facts

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