V5 Ultimate
Compliance

Personnel hygiene (21 CFR 111.10)

TL;DR

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 engineered into every action, not bolted on.
Because V5 owns the operator action, the QMS sees the data the second it’s captured — not at the end of the shift.
Document control with hard kiosk-level training enforcement.
Versioned SOPs are only useful if operators are actually trained on the current version. V5 enforces it at the kiosk.
Related terms
Sanitation (21 CFR 111.15)
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