GMPs for Dietary Supplements: 21 CFR 111 Subparts G, L, M, N, O and Compliance
About This Course
This self-paced course covers the requirements for dietary supplement packaging and labeling systems, applicable even if these are the only operations at your facility. Also covered in this module are the requirements for warehousing and distribution of dietary supplements and the FDA regulations for procedures involving product complaints and returns. The following subparts of 21 CFR 111 are covered:
- Subpart G - Components, Packaging and Label Control
- Subpart L - Packaging and Labeling Control System
- Subpart M - Holding and Distributing
- Subpart N - Returns
- Subpart O - Complaints
This module also reviews what to expect during an FDA inspection and how to be prepared for one.
Key Learning Objectives
By the end of this module, you will gain knowledge of:
- The importance of label control and implementation.
- The importance of environmental monitoring in holding and distribution operations.
- The requirements and procedures for handling returned products.
- The process for handling product complaints.
- What to expect in an FDA inspection and what is exempt.
- How to implement cGMPs at your facility.
- The written procedures, documents and records required to be compliant with the requirements of subparts G, L, M, N and O.