In a risk-based inspection (RBI), Schedule M – point 4.17 (as captured in the CDSCO RBI checklist under water systems) is treated as a critical utility control because Water for Injection (WFI) can rapidly become a contamination source if storage/distribution…
Risk Based Inspection (RBI) – Schedule M Point 4.16 focuses on one core question in sterile manufacturing: Is Water for Injection (WFI) actually being used where Schedule M expects it, and is the use controlled and documented? In the CDSCO…
In Risk-Based Inspection (RBI), Schedule M points 4.14–4.15 are treated as critical utility controls because failures in WFI storage/sanitization or WFI quality can directly cause microbial/endotoxin contamination in sterile products. 4.14: Sanitization process of SS WFI storage tank This checkpoint…
Risk Based Inspection (RBI) – Schedule M Point 4.13 checks “What is the process for preparation of Water for Injection (WFI)?” and expects a clear, validated, GMP-controlled description from PW feed to WFI storage CDSCO Under Schedule M (sterile products…
Risk Based Inspection (RBI) – Schedule M Point 4.12 (Purified Water used for WFI) In a risk based inspection, Schedule M point 4.12 focuses on verifying that the quality of Purified Water used for the preparation of Water for Injection…
In a risk-based inspection (RBI), Schedule M point 4.11 (Water & Compressed air system section of the CDSCO benchmark checklist) requires the inspector to confirm whether the quality of potable water used for preparation of Purified Water meets Schedule M…
Risk-Based Inspection (RBI) is a GMP approach where regulators plan the frequency, depth and breadth of inspections according to the estimated risk to patients and product quality, using Quality Risk Management and risk signals from a site’s history. Schedule M…
Risk Based Inspection (RBI) – Schedule M Point 4.9 (Microbiological detection levels for EM limits) In RBI, inspectors focus more deeply on contamination control because failures can directly affect patient safety. Risk-based inspection planning typically varies the frequency, depth, and…
Risk-Based Inspection (RBI) rates a site by the risk it may pose to patients and product quality and then decides the frequency, depth and breadth of inspection accordingly, using Quality Risk Management. CDSCO In Schedule M (Sterile Products), points 4.5–4.8…
Risk-Based Inspection (RBI) lets regulators decide the frequency, depth and breadth of GMP inspections using Quality Risk Management, focusing more effort on systems that could impact patients, product quality, and users. CDSCO Schedule M – Point 4.4 (What it requires)…
In a risk-based inspection (RBI), Schedule M points 4.1–4.3 (in the CDSCO RBI checklist under Water & Compressed air system) are treated as critical utility controls, because an uncontrolled water system can cause microbial/chemical contamination, endotoxin risk, and batch impact…
In a risk-based inspection (RBI), Schedule M (Sterile Products) points 3.1–3.4 “Sanitation” are assessed as direct controls for sterility assurance and contamination control—because ineffective cleaning/disinfection can immediately impact Grade A/B/C/D areas and lead to environmental excursions or sterility failures. 3.1…