In a risk-based inspection (RBI), Schedule M point 6.1 is assessed as a foundational sterility assurance control because it defines how a facility prevents microbial, particulate, and pyrogen contamination through an effective cleaning and disinfection system. Point 6.1 expects that an appropriate cleaning and disinfection program is established and followed, and that disinfectants used in clean/aseptic areas are suitable and controlled for intended use.
What inspectors verify under RBI (evidence, not just SOP)
- Written sanitation program: frequency and responsibilities by room grade (A/B/C/D), defined methods (wiping/mopping/fogging where justified), and clear “clean-to-dirty” direction. Inspectors cross-check schedules against executed logs.
- Selection of disinfectants: justification that agents cover expected flora (bacteria/fungi/spores) and are compatible with surfaces/equipment. RBI checks whether disinfectants are approved via QA and supported by effectiveness studies (e.g., in-house/third-party validation against isolates).
- Preparation and control: correct dilution water quality, validated filtration/sterilization where required for aseptic grades, defined “use before” periods, labelling (name, concentration, prepared by/checked by, expiry), and container cleaning status.
- Application parameters: correct contact time, wipe technique, wetness maintenance, and prevention of aerosolization in critical areas. Inspectors often observe operators to confirm technique matches SOP.
- Monitoring and trending: link between sanitation and environmental monitoring trends—how the site responds to rising counts, recurring organisms, or shift/operator patterns. Investigations should show root cause and CAPA (e.g., change in frequency, sporicide inclusion, retraining).
- Cleaning validation/residue control: evidence that residues from detergents/disinfectants are controlled/removed to avoid product contact contamination and surface buildup (sticky films can trap microbes).
Common RBI red flags
“Tick-box” logs, expired/incorrectly labelled solutions, no contact-time control, disinfectants not proven effective against site flora, and repeated EM excursions without meaningful CAPA.