US FDA

21 CFR Part 211 Module 2: Buildings & Equipment

Facility design and construction requirements under Subpart C, and equipment design, cleaning and maintenance requirements under Subpart D.

What this course covers

This module covers Part 211's buildings and facilities requirements, including ventilation, air filtration, plumbing, sanitation and maintenance, alongside the equipment requirements in Subpart D: equipment design, size and location, contact surface construction, cleaning and maintenance logs, and the specific requirements that apply to automatic, mechanical and electronic equipment.

Who this course is for

Facilities and engineering staff involved in site design or renovation
Equipment qualification and maintenance teams
QA staff reviewing facility or equipment change controls

What you'll learn

Building and facility design requirements under Subpart C, including ventilation and air filtration
Sanitation and maintenance expectations for production and storage areas
Equipment design, size, location and contact surface requirements under Subpart D
Equipment cleaning, maintenance and use-log documentation expectations
Requirements specific to automatic, mechanical and electronic equipment

Why it matters

Facility and equipment findings are among the most expensive to remediate because they often require construction or capital investment to fix, not just a procedure rewrite. Understanding these requirements before a build-out or equipment purchase avoids costly rework after the fact.

Included in the full GMPify subscription

Completion certificate, PDF slide download, and access to the complete GMP course library from day one.

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