In a risk-based inspection (RBI), Schedule M points 6.2–6.8 are assessed as core contamination-control controls for sterile/aseptic processing. Inspectors don’t just confirm the SOP exists—they test whether sanitation practices reliably prevent microbial and particulate contamination and whether failures would be detected early.
6.2 – Rotation and concentration of sanitizers: RBI verifies that different sanitizing agents are rotated (to reduce microbial adaptation) and that working concentrations match manufacturer recommendations, with rotation records maintained. Inspectors check preparation sheets, issue logs, and whether QA reviews trends in environmental isolates against the sanitizer program. IPA Pharma
6.3 – Water used for disinfectant dilution: Inspectors confirm disinfectants are diluted only with fresh distilled water, hot loop water (>70°C), or sterilized distilled water (autoclaved or membrane filtered), and that dilution is done in the “white” change room to limit bioburden. RBI evidence includes water system logs, sanitization/temperature records, and microbiological monitoring.
6.4 – Alcohol/isopropyl hand-spray preparation: If alcohol/isopropyl is used for hand sprays, RBI checks it is prepared in the bulk preparation area and the diluted solution is membrane filtered into sterile containers held in the aseptic area—reducing bioburden and particulate risk from transfer/handling.
6.5 – “Use before” dating and labeling: Inspectors verify expiry (“use before”) is scientifically set based on microbiological establishment of germicidal properties, and that containers are adequately labeled with documents maintained (traceability, status control, mix-up prevention).
6.6 – Fumigation controls: RBI confirms fumigation (e.g., formaldehyde or equivalent) is reserved for aseptic-area fumigation or after major civil modifications, controlled by SOPs, and discouraged for routine use in favor of an effective surface-cleaning regime. Qualification and post-fumigation recovery data are key.
6.7–6.8 – Cleaning tools and particle monitoring: Inspectors check cleaning uses air-suction devices/ non-linting wipes to avoid fiber shedding, and that air particulate quality is regularly evaluated with records and trend review against alert/action limits.