In the Risk-Based Inspection (RBI) checklist, Schedule M – Point 39.21 requires inspectors to verify the procedure for handling and disposal of chemical and microbial waste (typically assessed in/around the microbiology laboratory and related waste handling areas). CDSCO
What the requirement is trying to control (risk intent)
Chemical reagents/solvents and microbiology waste (cultures, plates, pipette tips, contaminated PPE, media, etc.) can create three major risks:
- Product quality risk (cross-contamination/backflow into clean areas),
- Personnel safety risk (exposure/infection/chemical burns),
- Environmental & regulatory risk (non-compliant disposal).
Schedule M broadly expects sewage/effluent and biomedical waste disposal to comply with pollution control and biomedical waste provisions, with records maintained.
What inspectors typically check under 39.21
1) SOP system (must exist and be implemented)
- A dedicated SOP covering: waste identification, segregation, labeling, internal transport, temporary storage, decontamination/inactivation, and final disposal route. CDSCO
- Defined responsibilities (QC Micro, EHS, housekeeping, QA oversight) and training records.
2) Segregation and containment
- Separate streams for microbial/biohazard waste vs chemical waste (and sharps/glass where applicable).
- Correct, labeled containers, closed bins, and controlled movement to avoid spills and mix-ups.
3) Decontamination/inactivation controls
- Evidence that microbial waste is rendered safe (e.g., validated autoclave cycle or approved chemical disinfection), including cycle parameters, load patterns, indicators, and logbooks.
4) Storage and disposal pathway
- Defined holding time, safe storage area, and documented handover to authorized disposal/effluent systems (as applicable), with traceability.
5) Records and trending
- Waste generation logs, disposal records/manifests, deviations (spills, excursions), investigations and CAPA—showing the system is in control, not just “written.”
In short, 39.21 is passed when there is a clear SOP + trained execution + validated/in-controlled decontamination + compliant final disposal + complete records