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Risk Based Inspection (RBI) – Schedule M Point 4.26 asks the firm to “Specify the arrangement for preparation of pure steam & its use.” CDSCO In RBI, this is treated as a critical utility check because pure steam is commonly…

Risk-Based Inspection (RBI) under India’s CDSCO approach uses Quality Risk Management to decide the frequency, depth and breadth of inspection based on the site’s risk to patients/product quality, and then applies a structured checklist (Schedule M + WHO + PIC/S…

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…