In a risk-based inspection (RBI), Schedule M (Sterile Products) points 3.1–3.4 “Sanitation” are assessed as direct controls for sterility assurance and contamination control—because ineffective cleaning/disinfection can immediately impact Grade A/B/C/D areas and lead to environmental excursions or sterility failures.
3.1 – Cleaning program, disinfectant rotation, monitoring, and cleaning validation
Inspectors verify that clean areas are cleaned frequently and thoroughly per an approved written programme, and that more than one disinfectant is used (rotation). RBI goes beyond “SOP exists” to check effectiveness evidence: EM trends (air/surface/personnel), recurring flora, and whether investigations link failures to cleaning practice. Inspectors also look for validation that interactions between cleaning agents are understood, and that cleaning validation can detect and remove disinfectant residues after use.
3.2 – Bioburden control of disinfectants/detergents and sterile use in Grade A/B
RBI verifies controls preventing disinfectant solutions themselves becoming contamination sources: monitoring for microbial contamination, preparation in clean containers, defined hold times for dilutions (or sterilization where applicable), and the requirement that disinfectants/detergents used in Grade A and B are sterile before use. Inspectors review preparation logs, filtration/sterilization records, container cleaning status, and expiry/“use before” labelling.
3.3 – Inclusion of sporicidal agent and demonstrated effectiveness
Inspectors confirm the disinfectant programme includes a sporicidal agent, since many routine disinfectants are ineffective against spores, and that the effectiveness of cleaning/disinfection is demonstrated (e.g., validation, in-use studies, EM trend response to sporicide frequency).
3.4 – Fumigation as a controlled, justified measure
RBI checks whether fumigation is used appropriately (typically for inaccessible places or post-intervention), with SOP control, safety, cycle parameters, and post-fumigation recovery/EM requirements before restart.
Common RBI red flags: single disinfectant for years, weak residue control, non-sterile solutions used in Grade A/B, and no data proving sporicidal effectiveness.