GMPs for Dietary Supplements: 21 CFR 111 Subparts E, K, F and J

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