RISK BASED INSPECTION [SCHEDULE M & WHO TRS 986-POINT (12.1-12.3)] means inspectors spend more time and deeper sampling on GMP systems that present higher patient/product-quality risk (e.g., contamination, mix-ups), and they test whether controls are effective in practice, not just written. ECA Academy+1
Schedule M + WHO TRS 986 (12.1–12.3): Premises design and dust-risk control
12.1 Premises must suit intended operations
WHO TRS 986 states the principle: premises must be located, designed, constructed, adapted and maintained to suit the operations performed.
Revised Schedule M repeats this expectation and additionally requires premises to conform to applicable conditions of the Factories Act, 1948.
RBI focus: Inspectors assess whether the facility design prevents contamination and errors for the actual product/process risk (e.g., hormones, β-lactams, potent powders). They verify zoning, segregation concepts, and whether the building condition/finishes support sanitation and controlled operations.
12.2 Layout/design must minimize errors and enable cleaning
WHO requires layout/design that minimizes errors and permits effective cleaning and maintenance to avoid cross-contamination and dust/dirt build-up.
Revised Schedule M similarly requires layout/design that minimizes errors and permits effective cleaning/maintenance to avoid cross-contamination and adverse product quality impact.
RBI focus: Inspectors “walk the flow” (people/material/waste) and challenge:
- Are flows logical and one-way where needed?
- Are there mix-up barriers (line/area status labeling, physical segregation)?
- Are cleaning access, drains, surfaces, and maintenance practices preventing contamination introduced during repairs?
12.3 Dust generation must be controlled
RISK BASED INSPECTION [SCHEDULE M & WHO TRS 986-POINT (12.1-12.3)] requires that where dust is generated (sampling, weighing, mixing, processing, powder packaging), measures are taken to avoid cross-contamination and facilitate cleaning.
Revised Schedule M explicitly calls for measures to avoid cross-contamination and facilitate cleaning where dust is generated in similar operations.
RBI evidence checks (typical):
- Containment/dust extraction effectiveness at dispensing/blending (capture velocity, housekeeping, “no dust travel”).
- HVAC/pressure regime supporting segregation; maintenance records and deviations when controls fail.
- Cleaning procedures + logs, and where justified, cleaning validation/verification for shared equipment/areas.
If dust controls are weak, RBI usually expands into cross-contamination risk assessment, sanitation effectiveness, and deviation/CAPA robustness.