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In a risk-based inspection (RBI), Schedule M point 34.3 evaluates a high-severity packaging risk: “Whether packaging lines are independent and adequately segregated.” CDSCO+1 Packaging is a final, patient-facing control point, so poor line segregation can lead to mix-ups (wrong product/strength/expiry),…

Risk-Based Inspection (RBI) means the inspector decides the depth and sampling intensity based on patient/product-quality risk—packaging controls are always high-risk because failures can cause wrong product/strength, wrong batch/expiry, or wrong label. A risk-based approach is commonly described as enabling the…

Risk-Based Inspection (RBI) – Schedule M Point 33.4 verifies “whether all the documents generated during batch production are attached with the BPR” CDSCO Under RBI, this is a high-priority documentation control because missing attachments weaken traceability, investigation quality, and batch…

In Risk-Based Inspection (RBI), Schedule M & WHO TRS 986 points 33.1–33.3 are used to judge whether your Batch Production/Manufacturing Record (BPR/BMR) is a reliable, end-to-end “story” of how the batch was made—strong enough to prevent/trace mix-ups, contamination, and undocumented…

In a risk-based inspection (RBI), Schedule M & WHO TRS 986 (Points 32.1–32.4) are evaluated under Master Formula Records (MFRs) because weak master documentation is a top driver of wrong process execution, wrong quantities, mix-ups, and repeat deviations. 32.1 –…

Risk-based inspection (RBI) of “Labels and Other Printed Materials” under Schedule M and the CDSCO/WHO-aligned checklist (WHO TRS 986 points 31.1–31.4) treats labelling as a high-impact risk area because mix-ups and mislabelling can directly harm patients and trigger recalls. Inspectors…

In a risk-based inspection (RBI), Schedule M points 15.6–15.8 are checked as practical error-prevention controls in manufacturing areas—because poor visibility and weak changeover discipline directly increase risks of mix-ups, wrong setting/reading, poor cleaning, and missed defects. 15.6 – Production area…

Risk-Based Inspection (RBI) is a methodology that rates manufacturing sites by the risk they may pose to patients and product quality, and then determines the frequency, depth and scope of GMP inspection accordingly. CDSCO For Schedule M points 15.1–15.5 (Sanitation…

Risk-Based Inspection (RBI) – Schedule M & WHO TRS 986 (14.16–14.20) concentrates on dispensing controls and mix-up prevention, because a single wrong weighment or wrong component can affect every unit in the batch. What these points require (combined intent) Identity…

Risk-Based Inspection (RBI) is a GMP approach where regulators rate a site’s risk to patients and product quality and then decide the frequency, depth and breadth of inspection accordingly. cdsco.gov.in RBI site selection also considers signals like complaints, NSQ history,…

Risk Based Inspection (RBI) – Schedule M Points 14.6 to 14.9 are assessed under “Precautions against mix-up and cross-contamination” and check whether your facility has practical, documented controls to prevent cross contamination and packing mix-ups. CDSCO+1 14.6 – Prevent contamination…

In a risk-based inspection (RBI), Schedule M points 14.3–14.5 are examined as high-impact controls because they govern how a firm handles nonconforming APIs/intermediates, recovered materials/solvents, and returned goods—all common sources of hidden quality defects, impurity drift, contamination, and data integrity…