--------------------------------------------------------------------- | COMPANY NAME (Confidential) | | BATCH MANUFACTURING RECORD (BMR) | | Product: Paracetamol 500mg Tablets Batch No: P-2409-01 | | Manufacturing Date: _______ Expiry: _______ MBR Ref: M-01| --------------------------------------------------------------------- | Section 1: Raw Material Reconciliation | | API: Paracetamol (Lot: API-22A) Theo: 100kg Actual: 100.1kg | | Excipient: Starch (Lot: ST-11B) Theo: 20kg Actual: 19.98kg | | Operator: _______ Checker: _______ | --------------------------------------------------------------------- | Section 2: Granulation (Step 1) | | Load API into Diosna P25. Start mixing at 150 RPM. | | Actual RPM: ____ Start Time: ___:___ End Time: ___:___ | | Granulation fluid added? Yes / No Volume: ____ mL | | Operator Sign: _______ | --------------------------------------------------------------------- | Section 3: In-Process Control (Tablet Compression) | | Target Hardness: 8-10 kP Actual: 9.2 kP (Pass) | | Avg Weight: 650mg ±5% Actual Avg: 652mg (Pass) | | Inspector Sign: _______ | --------------------------------------------------------------------- | Section 4: QA Release | | Discrepancies found? Yes / No. Deviation Ref: D-101 | | QA Approval: _______ Status: [] Reject [] Release | ---------------------------------------------------------------------
BMRs are essential in the pharmaceutical industry for several reasons...
: A precise list of all raw materials, including their quantities, internal codes, and Certificate of Analysis (CoA) references. Equipment & Line Clearance
