Risk-Based Inspection (RBI) plans the frequency, depth, and scope of GMP inspections by rating a site’s risk to patients and product quality, using Quality Risk Management principles. CDSCO Under RBI, HVAC exhaust and dust handling systems are treated as high-risk because failures can drive cross-contamination, occupational exposure, and re-entrainment of contaminated air.
Schedule M Point 9.10–9.13: What the requirements mean
9.10 Filter decontamination bypass
A bypass arrangement should allow circulation through HEPA filters while ports are open, and also permits filter decontamination by circulating a sanitizing agent. This is intended to manage high-risk maintenance/testing activities without releasing contamination.
9.11 Safe-change filtration for exhaust
All major exhausts (e.g., dust extraction, vacuum exhaust, fluid bed dryer exhaust, coating pan exhaust) must pass through safe-change filter housings before discharge to atmosphere—so contaminated filters can be changed without operator/environment exposure.
9.12 Exhaust discharge placement
Exhaust discharge points must be positioned as far as possible from air intakes, with discharge at a high level, and placement must consider dominant/seasonal wind directions to minimize re-entrainment of exhaust air back into the facility.
9.13 Dust collectors/bag houses for heavy dust
Where air is excessively dust-laden, a dust collector/bag house should be used, located in an enclosed negative-pressure room, with access control, trained maintenance, and appropriate PPE and breathing air systems for safe dust removal.
What RBI inspectors typically verify (practical evidence)
- Design & qualification evidence: airflow diagrams, segregation concept, DQ/IQ/OQ where applicable, and justification for bypass/decontamination approach.
- Filter integrity + safe-change practice: HEPA/secondary filter integrity test records, “bag-in/bag-out” or safe-change SOPs, maintenance logs, and deviation/CAPA for any filter failures (and documented product impact review where relevant).
- Environmental control at discharge: intake–exhaust distance checks, discharge height verification, and documented wind-direction consideration during design changes.
- Dust handling discipline: negative-pressure room monitoring, controlled access, PPE/breathing air qualification, and housekeeping around dust bins/collector changeouts.
In RBI terms, repeated dust leaks, unsafe filter changes, or re-entrainment risk usually triggers deeper inspection sampling and stronger regulatory follow-up because the potential impact is both product contamination and operator safety.