7 – FDA 21 CFR Part 211 Equipment (S14E4)

59 min • 10 maj 2025

This episode dives into Subpart D of 21 CFR Part 211, focusing on the regulations governing equipment used in pharmaceutical manufacturing. We examine the requirements for equipment design, maintenance, cleaning, and qualification. The discussion highlights how proper equipment calibration and periodic validation are essential for supporting reliable manufacturing outcomes. The conversation explores the importance of a risk-based approach to equipment management, illustrating how companies prioritize their efforts.

We emphasize the significance of detailed documentation and preventive maintenance plans in ensuring that equipment consistently meets performance criteria. We highlight reducing the risk of errors or contamination during production. The episode underscores how every aspect of equipment management, from initial design to ongoing maintenance, contributes to the overall quality and safety of the final product. We also touch upon emerging technologies and how they are impacting equipment management practices in the pharmaceutical industry.