Current Good Manufacturing Practices Course
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.