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HomeGlossaryPersonnel hygiene (21 CFR 111.10)
Compliance

Personnel hygiene (21 CFR 111.10)

In short

21 CFR 111.10 sets the personnel rules for supplement plants: clean outer garments, hand washing, gloves where contact requires, no eating/drinking/tobacco/gum in production, exclusion of personnel with illness or open lesions that could contaminate components or product, and ...

21 CFR 111.10 sets the personnel rules for supplement plants: clean outer garments, hand washing, gloves where contact requires, no eating/drinking/tobacco/gum in production, exclusion of personnel with illness or open lesions that could contaminate components or product, and visitor controls. Plus training in cGMP and the specific operation, documented, before independent work. Gowning gowns/hairnets/beard covers are the visible 483 trigger.

Regulatory anchors
  • 21 CFR 111.10
  • 21 CFR 111.13
  • 21 CFR 111.14
How V5 handles it
QMS — quality records next to the work they concern.
Deviations, corrective actions and quality review sit in the same system as production, so each quality record references the work order, step and lot it concerns.
Document control — one version in force, every change signed and explained.
Draft the next revision while the current one stays in use, approve it under your sign-off route, and track training on it — with the history kept.
Related terms
Sanitation (21 CFR 111.15)
Software that covers Personnel hygiene (21 CFR 111.10)
V5 Ultimate (Dietary Supplements)
V5 Ultimate runs Master Manufacturing Records and executed Batch Production Records under 21 CFR Part 111, with mandatory…
V5 Ultimate Dietary Supplements
Written for supplement contract manufacturers and brand owners tired of surviving FDA 483s on paper.
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