Risk-Based Inspection (RBI) is a GMP inspection approach where regulators plan inspection frequency, depth and scope based on estimated patient/product-quality risk and a site’s compliance history, using Quality Risk Management principles. cdsco.gov.in
Schedule M + WHO TRS 986 focus: Points 13.6–13.10 (Equipment controls)
In the revised Schedule M and WHO TRS 986 (Annex 2), clauses 13.6–13.10 strengthen core equipment-related contamination and mix-up controls:
- 13.6 Cleaning by schedule: production equipment must be thoroughly cleaned according to a fixed schedule (not “as needed”).
- 13.7 Fitness for purpose (QC instruments): laboratory equipment/instruments must be suited to the testing procedures (adequate range, sensitivity, suitability).
- 13.8 Cleaning utilities not a contamination source: washing/cleaning/drying equipment must be selected and used so it does not introduce contamination (e.g., dirty washers, non-qualified dryers, poor drainage).
- 13.9 Product contact safety: product-contact parts must not be reactive, additive or absorptive enough to affect product quality (material of construction, surface finish, gaskets, lubricants, corrosion control).
- 13.10 Defective equipment control: defective equipment must be removed from production/QC areas, or clearly labelled to prevent use.
What an RBI typically verifies on-site (evidence-based)
Because failures here can directly cause cross-contamination, OOS/OOT results, mix-ups and stability failures, RBI will usually prioritize:
- Cleaning governance: approved cleaning SOPs, cleaning schedules, cleaning logs, line-clearance records, and (where required) validated cleaning procedures with scientifically justified acceptance limits and periodic verification.
- Equipment status control: clear “clean/dirty/in-use/under maintenance/defective” status labelling, segregation of defective parts, and controls preventing use of quarantined equipment.
- QC instrument suitability & data reliability: instrument qualification/calibration status, system suitability checks, maintenance logs, and trend review of breakdowns/repeat failures.
- Contamination risk assessment: documented risk assessments for shared equipment, difficult-to-clean designs, and product-contact material compatibility (especially with potent, sensitizing, or low-dose products).
A strong RBI outcome here is not just “procedures exist”, but clear proof that equipment cleaning, suitability and defect controls are implemented, reviewed, and effective.