Risk-Based Inspection (RBI) allocates inspection depth and sampling to systems with the highest patient/product-quality risk, using a structured risk approach for GMP inspections. CDSCO
Note: “9.7–9.9” covers different topics in Schedule M (HVAC filtration controls) versus WHO TRS 986 (key personnel), so RBI verifies both in their own context.
Schedule M (9.7–9.9): HVAC filter integrity and safe-change containment
9.7 requires filter differential pressure gauges to be marked with clean-filter resistance and change-out resistance so operators can clearly judge filter loading and replacement point.
RBI focus: inspectors check calibration, daily/shift checks, alarm/action practices, and whether “change-out” decisions are documented and justified (not delayed until failures).
9.8 requires installed filter leakage tests per ISO standards and mandates upstream injection ports and downstream access ports to perform integrity testing correctly.
RBI focus: integrity test frequency, protocols, aerosol/scanning method, deviation handling for leaks, product-impact assessments, and CAPA effectiveness. Missing ports, poor access, or repeated “patching” without investigation typically increases RBI scrutiny.
9.9 requires the exhaust fan on a safe-change filter system to be located after the filters so the housing stays at negative pressure; it also expects a bypass damper/booster fan arrangement so air can be circulated through HEPA filters while scanning ports are open (supporting safe integrity testing and potential decontamination setups).
RBI focus: containment performance during maintenance, safe-change (bag-in/bag-out) practices, PPE, cleaning after interventions, and evidence that contaminated exhaust cannot leak back to clean areas.
WHO TRS 986 (9.7–9.9): Key personnel competence and responsibilities
9.7 requires key personnel supervising production/quality to have suitable scientific education and practical experience.
9.8 defines shared quality responsibilities (e.g., procedures, environment control, hygiene, validation/calibration, training, supplier control).
9.9 lists key responsibilities of the Head of Production (produce/store per documentation, approve production instructions, review records, ensure maintenance/validation/training).
RBI verification: organization chart, job descriptions, independence of quality, decision trails, competence evidence, and whether these leaders actually control high-risk utilities like HVAC—not just “on paper.”