Risk-Based Inspection (RBI) is a GMP approach where regulators adjust inspection frequency, depth and scope based on the estimated risk to patients and product quality (and can widen scope when risk signals appear). ECA Academy
In Schedule M, Point 5.3–5.4 controls the QC laboratory design and segregation—because weaknesses here can generate unreliable test results, leading to incorrect batch release decisions.
What Schedule M 5.3–5.4 requires
5.3: The QC lab design must consider suitable construction materials and ventilation; it requires separate air-handling units (AHUs) and related provisions for biological, microbiological and radioisotope testing areas, and a regular supply of water of appropriate quality for cleaning and testing.
5.4: The QC lab must be divided into separate sections for chemical, microbiological and (where required) biological testing, with adequate area for basic installations and ancillary activities. The microbiology section should include arrangements such as airlocks and laminar airflow work stations wherever necessary.
How RBI typically inspects these points (risk focus)
- Mix-up and cross-contamination risk: sample receipt controls, unique ID/traceability, segregation of test samples vs retained samples vs reference standards/reagents/records; cramped benches or shared spaces are treated as high-risk.
- Microbiological integrity risk: airlock effectiveness, airflow discipline, and LAF/BSC (where used) to prevent false positives/negatives that can mislead investigations and release decisions.
- Facility fitness for instruments: stability of temperature/RH, dust control, vibration/noise (as relevant), and reliable utilities (power backup for critical instruments) so results are reproducible.
- Water quality risk: defined specification for QC water use, monitoring/trending, and point-of-use controls so cleaning/dilution water cannot bias results.
Evidence inspectors commonly check
- Layout vs actual operations (people/material flow, access control, zoning).
- HVAC/AHU qualification & maintenance, deviations and CAPA for excursions.
- LAF/BSC certifications, cleaning/disinfection logs (micro areas).
- Water test results and logs linking water use to testing/cleaning activities.
Frequent RBI findings: shared/poorly controlled AHUs, ineffective airlocks/LAF certification gaps, uncontrolled storage of standards/reagents, and weak documentation linking results to controlled lab conditions—often expanding review into OOS handling and batch release governance.