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:
By the end of this module, you will gain knowledge of:
Dietary Supplement GMPs Overview: 21 CFR 111 and Subparts A, P, H and I
GMPs for Dietary Supplements: 21 CFR 111 Subparts B, C and D