GMP's for Dietary Supplements - 21 CFR 111 Subparts E, K, F & J (Module 3)

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.