| QA Checklist for Review of BMR |
| Product Name: Batch No. Batch Size: Sr. No. Item to be checked Inference of Q.A. Personnel Remarks 1 BMR is an accurate reproduction of current Master Manufacturing Record Yes / No 2 All the issued pages are available. Yes / No 3 Dispensed and checked by BMR against each raw material are signed, dated by concerned personnel. Yes / No 4 Any extra material produced through supplementary material requisition with proper justification. Yes / No 5 Batch Number Mentioned correctly on all pages. Yes / No 6 Correct manufacturing date and expiry date is assigned. Yes / No 7 Adjustment of Quantity of active ingredients as per instructions in batch records. Complete/ incomplete 8 Issuing of raw materials. Complete/ incomplete 9 Weighing record of raw materials. Complete/ incomplete 10 Material details labels. Complete/ incomplete 11 Area cleaning and clearance record. Complete/ incomplete 12 Equipment cleaning and clearance. Complete/ incomplete 13 BMR manufacturing instruction: All manufacturing instructions followed and accurately documented with respect to identify of equipment used mixing, drying, loading and blending time durations, etc. with sign, and date of personnel performed the activity and checked by supervisor. Complete/ incomplete 14 Environmental conditions are with in the specified limits. Complete/ incomplete 15 In-process check records during tablet compression. Complete/ incomplete 16 In-process check records during coating. Complete/ incomplete 17 In-process check records during capsule filling. Complete/ incomplete 18 Details of sampling performed. Complete/ incomplete 19 Phase wise yield reconciliation done. Complete/ incomplete 20 If yield is out side the limit is investigated and justified. Complete/ incomplete 21 Any deviations / CCP are appropriately documented investigated and disposed. Complete / incomplete 22 No. of additional page issued in BMR Q.A. Checklist for Review of BPR Product Name: Batch No. Batch Size: Sr. No. Item to be checked Inference of Q.A. Personnel Remarks 1 BPR is completed. Yes / No 2 Finished Goods Transfer Details. Complete / incomplete 3 All the columns of “Done by and checked by” are filled in BPR. Complete / incomplete 4 Issuing of packaging material. Complete / incomplete 5 Verification of description and quantity of packaging material. Complete / incomplete 6 Packaging area / equipment cleaning and clearance. Complete / incomplete 7 BPR- packaging instruction: all packaging instruction steps filled out referencing equipment used, quantities, packed, signed and dated of personnel who perform the activity and checked by supervisor. Complete / incomplete 8 Expiry date assigned correctly and mentioned in all packaging records. Complete / incomplete 9 Specimen of coded labeling and literature. Complete / incomplete 10 In-process checks during packing operation. Complete / incomplete 11 Sample collection record. Complete / incomplete 12 Labels and packaging materials reconciliation record. Complete / incomplete 13 Review of finished product analytical records / other analytical records if any. Complete / incomplete 14 Analytical results and yield at every stage is as per the norms. Yes / No 15 Finished product release report. Complete / incomplete 16 Any deviations / CCP are appropriately documented, investigated and disposed. Complete / incomplete 17 Yield reconciliation in BPR Complete / incomplete 18 If Yield is out side the limit, if investigated and justified Complete / incomplete 19 No. of additional page issued in BPR |
