admin

In a risk-based inspection (RBI), Schedule M point 39.4 verifies a key sterility barrier: entry to the sterile area is through a three–airlock system with a separate exit. CDSCO Why this is high-risk: Personnel are the biggest contamination source in…

Schedule M – Point 39.3 (Microbiology Lab) in a Risk-Based Inspection (RBI) focuses on whether the firm has an appropriate microbiology laboratory layout and can briefly describe it (with a layout drawing, if available). CDSCO In RBI, this point is…

Risk-Based Inspection (RBI) – Schedule L1 Point 38.5 (QC Department Safety) asks: “Specify the safety measures taken to avoid any accidental hazards in the QC department.” Under RBI, this is treated as a high-impact, high-likelihood control because QC labs routinely…

In a risk-based inspection (RBI), Schedule L1 – Point 38.4 checks whether the QC laboratory has effective arrangements to protect sensitive electronic balances from vibrations, electrical interference, and humidity, because these factors can silently bias weighing results and cause wrong…

In a risk-based inspection (RBI), Schedule M point 34.16 checks a high-impact documentation risk: whether the Batch Production Record (BPR) is based on the current, approved Master Formula Record (MFR). If an outdated MFR is used, the batch may be…

Risk-Based Inspection (RBI) is an inspection planning approach where regulators priorities what to inspect and how deeply based on risk to patient safety and product quality, using Quality Risk Management to decide inspection frequency and scope. Schedule M – Point…

In Risk-Based Inspection (RBI), Schedule M checklist point 34.14 is used to verify whether the Batch Packaging Record (BPR) is complete against global GMP expectations, i.e., it “covers all the points as prescribed in WHO TRS 986 & PIC” CDSCO…

Risk-Based Inspection (RBI) – Schedule M Point 34.13 checks whether the Batch Packaging Record (BPR) covers all points prescribed in Schedule M. CDSCO Under RBI, packaging records are treated as high patient-risk because packaging errors can cause wrong label/strength, wrong…

In a risk-based inspection (RBI), Schedule M points 34.11–34.12 focus on preventing one of the most serious packaging failures: printed component misuse (wrong label/carton/foil/leaflet), which can cause mislabelling, mix-ups, and recalls. 34.11 – Destruction of excess printed packaging material (on…

Risk Based Inspection (RBI) – Schedule M Points 34.9–34.10 focus on packaging yield control and reconciliation, because packaging is one of the highest-risk stages for mix-ups, mislabeling, and undocumented losses. Point 34.9 (Immediate batch yield calculation) Inspectors verify whether batch…