Post Views: 2,158 A BMR (Batch Manufacturing Record) and BPR (Batch Packaging Record) checklist ensures each batch is made and packed exactly as approved, with complete traceability, GMP compliance, and data integrity. Below is a practical checklist used by QA…

Post Views: 1,016 Purified Water System 1) Feed water & pretreatmentPW usually starts from potable water. Pretreatment protects the purification equipment and typically includes multimedia filter (particles), activated carbon (removes chlorine), softener (hardness control), and cartridge filtration. Proper chlorine/chloramine control…

Post Views: 1,391 Purified Water (PW) system qualification in pharma is the documented proof that the PW system is designed, installed, operated, and performs consistently to deliver water meeting your defined chemical and microbiological requirements at all points of use—throughout…

Post Views: 1,259 In the Risk-Based Inspection (RBI) checklist, Schedule M – Point 39.21 requires inspectors to verify the procedure for handling and disposal of chemical and microbial waste (typically assessed in/around the microbiology laboratory and related waste handling areas).…

Post Views: 1,357 In a risk-based inspection, WHO TRS 986 – Point 39.17 (as used in the risk-based inspection checklist) requires inspectors to verify the firm’s procedure for (1) selecting environmental monitoring (EM) sampling locations and (2) interpreting EM results…

Post Views: 923 Risk Based Inspection (RBI) – Schedule M Point 34.14 (in the CDSCO RBI checklist) checks whether the Batch Packaging Record (BPR) for each batch covers all points required by WHO TRS 986 and PIC CDSCO What the…

Post Views: 801 WHO TRS 986 – checklist point 39.12 (RBI focus): the risk-based inspection checkpoint asks inspectors to verify that a documented procedure exists for dealing with spillages in a sterile area. In RBI, spillages are treated as a…

Post Views: 739 In a risk-based inspection (RBI), Schedule M point 39.8 (sterile products checklist) focuses on one of the highest contamination-risk activities: gowning to enter the sterile area, and it specifically requires inspectors to review the gowning procedure and…

Post Views: 852 Risk Based Inspection (RBI) – Schedule M Point 39.6 (as in the CDSCO RBI checklist) requires the inspector to verify the list of equipment used in the microbiological laboratory and to confirm that the equipment is placed…

Post Views: 897 Risk Based Inspection (RBI) – “Schedule M Point 39.5” in the CDSCO RBI checklist (mapped to WHO TRS 986) asks inspectors to verify: whether access to the sterile area is controlled, and if yes, what system is…

Post Views: 682 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…

Post Views: 576 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,…