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In WHO TRS 986 (Annex 2: GMP – main principles), Section 11 “Personal hygiene” is numbered 11.1 to 11.8 in the official text—there is no clause 11.13 in this edition. This “11.13” reference usually comes from internal RBI checklist renumbering…

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 CDSCO Risk Based…

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 renumbering, but the…

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 safely filtered/scrubbed before…

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. 11.5 – Emergency…

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 11.4 is a…

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 to handle starting…

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 hygiene failures can…

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 using Quality Risk…

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 risk and compliance…