8 – FDA 21 CFR Part 211 Control of Components and Drug Containers (S14E5)

18 min • 10 maj 2025

This episode explores Subpart E of 21 CFR Part 211, which focuses on the control of components, drug product containers, and closures. We detail the processes for receipt, identification, storage, and testing of raw materials, components, and packaging materials. The discussion highlights the importance of supplier qualification and control measures in ensuring the integrity of the entire supply chain. We analyze risk management.

The episode emphasizes how robust component control safeguards product integrity and minimizes risk throughout the manufacturing process. We examine traceability and accountabilty. Furthermore, we underscore the critical role of documentation in creating a complete history for every component. We discuss how these practices ensure that each element entering the production process meets the required quality standards. The aim is to illustrate how the seemingly mundane aspects of component control are, in fact, essential for successful manufacturing and regulatory compliance.