Post Views: 543 Risk-Based Inspection (RBI) plans the frequency, depth and breadth of GMP inspections based on estimated risk to patients/product quality, using Quality Risk Management. CDSCO Schedule M (RBI checklist) Point 11.12 – what it is about In the…

Post Views: 538 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: 849 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: 750 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: 599 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: 521 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: 526 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: 655 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: 647 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: 624 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: 528 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: 598 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…