Post Views: 534 In WHO TRS 986 (Annex 2: GMP – Main principles), Section 11 “Personal hygiene” runs from 11.1 to 11.8—there is no clause numbered 11.11 in this edition. In many RBI checklists, “11.11” is used as an internal…

Post Views: 847 WHO TRS 986 – Points 11.9–11.10 (as used in Risk-Based Inspection checklists) sit under HVAC/Air-handling controls and focus on preventing cross-contamination and re-entrainment of contaminated exhaust air back into clean areas. CDSCO 11.9: Exhaust systems must be…

Post Views: 746 In a risk-based inspection (RBI), WHO TRS 986 checklist points 11.5–11.8 are reviewed under HVAC/air handling risk control, because failures here can rapidly affect area classification, contamination control, and cross-contamination during routine operation, maintenance, and abnormal events.…

Post Views: 597 WHO TRS 986 – Point 11.4 (Personal hygiene) requires that all employees are instructed and encouraged to report to their immediate supervisor any conditions (relating to plant, equipment or personnel) that may adversely affect the product. Why…

Post Views: 514 WHO TRS 986 – Point 11.3 (Personal hygiene) in a Risk-Based Inspection (RBI) is a direct contamination-control requirement: any person with an apparent illness or open lesions that may adversely affect product quality must not be allowed…

Post Views: 515 In Risk-Based Inspection (RBI), WHO TRS 986 (Annex 2) points 11.1–11.2 are treated as frontline contamination-control barriers. Inspectors spend more time here when the site makes sterile products, high-risk dosage forms, or has contamination/complaint signals, because personnel…

Post Views: 644 Risk-Based Inspection (RBI) is a GMP inspection planning method that rates a manufacturing site by the risk it may pose to patients and to product quality, so regulators can decide the frequency, depth and breadth of inspection…

Post Views: 633 In WHO TRS 986 (Annex 2), 10.1–10.5 define the GMP training system inspectors expect to see working in practice—not just a “training file”. Under a risk-based inspection (RBI), regulators prioritize inspection depth and sampling based on public-health…

Post Views: 616 Risk-Based Inspection (RBI) plans the frequency, depth, and scope of GMP inspections by rating a site’s risk to patients and product quality, using Quality Risk Management principles. CDSCO Under RBI, HVAC exhaust and dust handling systems are…

Post Views: 524 Risk-Based Inspection (RBI) or RISK BASED INSPECTION [SCHEDULE M & WHO TRS 986-POINT (9.7-9.9)] allocates inspection depth and sampling to systems with the highest patient/product-quality risk, using a structured risk approach for GMP inspections. CDSCONote: “9.7–9.9” covers…

Post Views: 589 Risk-Based Inspection (RBI) or RISK BASED INSPECTION [SCHEDULE M & WHO TRS 986-POINT (9.1-9.6)] is a GMP inspection approach where the frequency, depth and breadth of inspection are adjusted based on estimated risk to patients/product quality. ECA…

Post Views: 694 In a risk-based inspection (RBI), Schedule M points 8.33–8.35 are checked as dispensing and material-control safeguards because failures here can directly cause mix-ups, cross-contamination, and safety/security breaches (especially with hazardous and controlled substances). 8.33 — Dispensed materials…