WHO TRS 986 – Point 11.3 (Personal hygiene) in a Risk-Based Inspection (RBI) is a direct contamination-control requirement: any person with an apparent illness or open lesions that may adversely affect product quality must not be allowed to handle starting materials, packaging materials, in-process materials, or finished medicines until the condition is no longer judged to be a risk.
RBI applies quality risk management so inspection effort increases where patient risk is higher, and where the manufacturer’s GMP history indicates weaker control. World Health Organization Since 11.3 is a “people-to-product” risk barrier, inspectors treat it as high-impact—especially for sterile, non-sterile liquids, low bioburden processes, and high-risk open operations (dispensing, sampling, aseptic set-ups).
What RBI inspectors typically verify for 11.3
1) A defined health/hygiene exclusion policy
- Written SOP defining what constitutes apparent illness and open lesions (e.g., fever/respiratory symptoms, diarrhea/vomiting, conjunctivitis, skin infections, uncovered cuts, weeping wounds).
- Clear rule that affected personnel are restricted from handling any materials/products covered by 11.3.
2) Practical reporting and decision-making pathway
- How employees report symptoms (self-reporting, supervisor observation, medical room/occupational health).
- Who decides restriction vs return-to-work (competent medical personnel/authorized process, not informal verbal decisions).
- How contractors/visitors are screened and restricted, consistent with hygiene controls applying to everyone entering production areas (linked principle in the same section).
3) Evidence the system works (not “paper-only”)
RBI will sample records and real cases:
- Logs of restricted duties, medical clearance, and return-to-work dates.
- Deviations/near-miss reports where someone was stopped from entering/handling due to illness/lesion.
- Supervisor shift records showing actions were timely and consistent.
4) Batch impact and CAPA when a breach occurs
If an ill/injured person handled materials, inspectors expect documented risk assessment, batch impact evaluation, and CAPA (e.g., retraining, improved screening, better first-aid coverage, glove policy changes), with effectiveness checks.
Common RBI observations
- No formal criteria for “illness/lesions,” reliance on verbal judgment.
- People kept on the line with bandages but no risk assessment.
- Missing documentation of restriction/return-to-work decisions—treated as a data integrity + contamination-control weakness under RBI.