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Current Good Manufacturing Practices Course

Current Good Manufacturing Practices Course

*Recently updated*

For 503A pharmacies who are considering expanding or have expanded their sterile compounding practice from 503A to 503B, this 2 lesson series provides required staff training on the U.S. Food and Drug Administration (FDA) and the current Good Manufacturing Practices (cGMPs). These lessons highlight:

  • differences between pharmacy and manufacturing practices;
  • specific requirements of the cGMPs; and
  • essential elements of a required quality system.

The Good Manufacturing eCourse is made up of 2 lessons with the following titles and learning objectives:

Lesson 1: Introduction to the cGMPs and FDA Oversight
  • Discuss the Code of Federal Regulations (CFR) and current Good Manufacturing Practices (cGMPs).
  • Explain how cGMPs apply to 503B Human Drug Compounding Outsourcing Facilities which are registered with the Food and Drug Administration (FDA.
  • Distinguish between the practice at 503A pharmacies and 503B Outsourcing Facilities.
  • List the basic elements of the FDA registration and inspection processes and discuss the enforcement actions which may be taken by the FDA.
  • Learn how to ensure quality and identify and use the building blocks of quality in any operation.
  • Gain a general understanding of what is expected from a 503B Outsourcing Facility registered with the FDA.
Lesson 2: cGMPs as they apply to Human Drug Compounding Outsourcing Facilities
  • Recall the general areas covered in the current Good Manufacturing Practices (cGMPs).
  • Recall specific examples of the cGMPs as they apply to a 503B Outsourcing Facilities.
  • Learn how to differentiate between 21 Code of Federal Regulations (CFR) 211 and the FDA draft interim or final guidances of 503B Outsourcing Facilities.