21 CFR 211.28 - Personnel Responsibilities - Gowning and Health

What it says

Personnel must wear clean clothing appropriate to their duties, protective apparel as necessary to protect drug products from contamination, and personnel with an apparent illness or open lesion that could adversely affect drug product safety or quality must be excluded from direct contact with components, product-contact surfaces or products until the condition is corrected.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• Gowning requirements scale with the risk of the specific operation, meaning aseptic processing areas carry materially more stringent clothing and gowning qualification expectations than general manufacturing areas.
• Health-based exclusion from production is a supervisory responsibility exercised in real time, not just a written policy - it depends on personnel actually reporting illness and supervisors acting on that information.
• Gowning qualification, particularly for aseptic operations, requires demonstrated competency, not simply the availability of appropriate garments.

What FDA inspectors look for

• Whether gowning qualification for personnel working in classified areas is documented, current, and includes objective assessment such as surface sampling after gowning.
• Whether a functioning system exists for personnel to report illness and for supervisors to act on that information before the person enters a production area.
• Whether personnel observed during a facility walkthrough are actually following the gowning and hygiene procedures documented for their area.

Related regulations