6 – FDA 21 CFR Part 211 Buildings and Facilities (S14E3)

29 min • 10 maj 2025

In this episode, we analyze Subpart C of 21 CFR Part 211, which sets forth the requirements for buildings and facilities used in pharmaceutical manufacturing. The discussion explores how facility design, construction, and environmental controls are crucial for minimizing contamination risks and maintaining product integrity. We explain the importance of factors like building layout, lighting, ventilation, sanitation, and even plumbing in creating a controlled environment. The episode paints a picture of these facilities as "contamination-proof fortresses".

We emphasize the importance of robust facility standards in enabling consistent compliance with cGMP. We also detail how regulatory inspectors evaluate these design elements during GMP inspections. Furthermore, we discuss how every detail, from air pressure to the materials used in construction, plays a critical role in ensuring product quality. The episode aims to highlight the often-unseen world of facility design and management and how it directly contributes to the safety and efficacy of medications.