Risk-Based Inspection (RBI) puts extra inspection depth on systems that best predict ongoing GMP control. A strong self-inspection report is one of those predictors because it shows whether the site can detect and correct risks between regulatory inspections. CDSCO’s risk-based inspection guidance also emphasizes using a structured, risk-focused approach to evaluate GMP compliance. CDSCO
Schedule M & WHO TRS 986 – Point 8.5: Self-inspection report (what it requires)
WHO TRS 986, Annex 2 (8.5) states that a report should be made at the completion of a self-inspection, and it should include:
(a) self-inspection results, (b) evaluation and conclusions, and (c) recommended corrective actions.
Schedule M aligns with the same expectation: the self-inspection procedure must be documented and should indicate results, evaluation, conclusions and recommended corrective actions, supported by effective follow-up.
How RBI evaluates “effectiveness” of 8.5 (what inspectors check)
RBI doesn’t accept “a report exists” as sufficient. Inspectors typically test whether the report is:
- Complete and traceable: scope/area audited, date(s), auditors, checklist or reference standards used, and objective evidence linked to each observation.
- Risk-based in conclusions: findings are prioritized (e.g., critical/major/minor or equivalent) and conclusions clearly state the risk to product quality/patient safety—especially for contamination control, mix-ups, data integrity, and sterile operations.
- Actionable in corrective actions: each recommendation translates into CAPA with an owner, due date, and required evidence for closure (not vague “retrain”).
- Consistent with reality: RBI walk-through interviews and floor observations match what the report claims (no “copy-paste” audits).
- Trend-aware: repeat observations are identified, trended, and escalated—showing the site learns and prevents recurrence.
Common RBI red flags
- Reports that list observations but lack evaluation/conclusions or don’t state product impact.
- “Recommended actions” without ownership, timelines, or effectiveness checks (weak follow-up linkage).
A robust 8.5 system produces reports that are evidence-based, risk-ranked, and CAPA-ready, making them strong proof of ongoing GMP control.