GMPs for Dietary Supplements: 21 CFR 111 Subparts E, K, F and J
About This Course
This self-paced course covers the requirements for specifications and guidance to establish them, which must be in place to ensure compliance with 21 CFR 111. Specifications for components, ingredients and in-process control points are critical to ensure finished product specifications are met.
This module also covers quality control responsibilities, laboratory requirements and guidance for conducting a root cause analysis and implementing effective corrective actions. The following subparts of 21 CFR 111 are reviewed:
- Subpart E – Production and Process Control
- Subpart K – Manufacturing Process Control
- Subpart F – Quality Control
- Subpart J – Laboratory Operations
Key Learning Objectives
By the end of this module, you will gain knowledge of:
- Where specifications are required and how to establish them.
- How to determine if specification requirements are met.
- The required content for a certificate of analysis (COA).
- How to address out-of-specification raw materials and finished products.
- How to prevent contamination.
- How to determine the root cause of a problem.
- The written procedures, documents, and records required to be compliant with the requirements of subparts E, K, F and J.
GMPs for Dietary Supplements: 21 CFR 111 Subparts G, L, M, N, O and Compliance
Dietary Supplement GMPs Overview: 21 CFR 111 and Subparts A, P, H and I