In WHO TRS 986 (Annex 2: GMP – main principles), Section 11 “Personal hygiene” is numbered 11.1 to 11.8 in the official text—there is no clause 11.13 in this edition. This “11.13” reference usually comes from internal RBI checklist renumbering or from a different WHO guideline.
If your intent is TRS 986 hygiene controls (most common “11.13” mis-reference)
The closest high-impact requirement that RBI teams often target is 11.8: personal hygiene procedures (including protective clothing) must apply to everyone entering production areas, including contractors and other non-employees.
RBI interpretation (what inspectors verify):
- Universal entry hygiene controls: written entry rules for employees/visitors/contractors (no exceptions), including gowning, hand hygiene, jewelry/cosmetics restrictions, and behavior rules.
- Access control + supervision: controlled entry points, escorts for visitors, entry logs, and supervision so untrained people don’t drift into open-product or critical zones.
- PPE governance: correct PPE issuance by area risk (e.g., head/face cover, gloves, dedicated footwear), laundering controls, replacement frequency, and prevention of cross-area PPE movement.
- Effectiveness evidence: real deviations/near-misses related to hygiene are recorded, investigated, and trended; repeat breaches trigger CAPA and effectiveness checks (not just “retrain and close”).
- Shop-floor interviews: operators can explain what must be reported and what actions to take for torn gloves, illness symptoms, accidental contact with product-contact surfaces, or gowning damage.
Because hygiene failures can immediately translate to contamination and batch impact, weak control here typically increases RBI sampling into sanitation, environmental monitoring, deviations/CAPA, and batch review.
If you truly meant “11.13” from WHO Data Integrity guidance
WHO TRS 1033 Annex 4 (data integrity) contains 11.13 on electronic signatures—requiring appropriate control (e.g., management oversight) and that e-signatures are attributable to an individual. World Health Organization
If that’s what your checklist is pointing to, RBI will focus on user access, uniqueness, audit trails, and preventing shared credentials.