Risk-Based Inspection (RBI) means planning frequency, depth and scope of GMP inspections based on patient/product risk, so high-risk systems get more time and tighter sampling of evidence. A well-known RBI model notes that a risk-based approach helps determine the frequency, depth and breadth of inspections and uses a quality risk management tool to rate sites by estimated risk to patients and product quality. Regulators like the US FDA also describe using a risk-based evaluation to prioritize manufacturing facilities for inspection. U.S. Food and Drug Administration
For Schedule M and WHO TRS 986, the RBI “system focus” for 8.29–8.32 is commonly interpreted as the self-inspection checklist items (i)–(l): (i) sanitation & hygiene, (j) validation/revalidation, (k) calibration, (l) recall procedures. These appear explicitly in Schedule M (Self-inspection items) and in WHO TRS 986 Annex 2 (Items for self-inspection).
8.29 Sanitation & hygiene (Self-inspection item i): RBI checks whether cleaning and disinfection programs are risk-based (area/product/toxin/bioburden), implemented as written, and trended. Inspectors look for cleaning validation links (worst case selection), EM excursions and investigations, cleaning log integrity, pest control, waste flow, personnel hygiene/gowning controls, and segregation to prevent cross-contamination. Weaknesses here directly raise contamination risk, so RBI expands sampling to high-risk rooms/equipment and reviews CAPA effectiveness.
8.30 Validation & revalidation (item j): RBI verifies a live validation lifecycle: VMP coverage, protocol/report completeness, deviation handling, continued process verification, and revalidation triggers after changes or adverse trends. Priority goes to sterile/aseptic operations, critical utilities, cleaning validation, and computerized systems where failure impacts data integrity and release decisions.
8.31 Calibration (item k): Inspect critical instruments (balances, probes, pressure gauges, timers, HPLC/GC systems) for calibration status, traceability to standards, overdue controls, and “out-of-tolerance” impact assessments on released batches. RBI deepens review where measurements control CPPs/critical tests.
8.32 Recall procedures (item l): RBI tests readiness: written recall SOP, roles, decision criteria, distribution traceability, effectiveness checks (mock recalls), regulatory communication, and reconciliation/disposition of returned stock. Poor traceability or delayed actions increases patient risk and pushes the site into higher inspection priority.