Procedure for Review of Batch Packing Record (BPR)

What is Batch Packing Record (BPR)

Batch Packing record is a written document of the batch from dispensing to dispatch stage which tells about the procedure and step wise instruction to be followed during the Packing of each batches. It contains actual data of the Packing and it is like a proof that batches were properly made and checked by the production and verified by Quality Assurance personnel. It also contains the details like Who has done the activity, when the done the activity etc.

Dispensing Stage :

  1. Ensure the Line clearance is verified by QA.
  2. Ensure the balance calibration date and due date is recorded.
  3. Ensure the label of ‘Dispensed Material’ is as per packing material requisition.
  4. Ensure the Sign & date of Weighed By and Checked By is completed.
  5. Quantity of material issued with respect to quantity as per packaging material requisition
  6. Ensure the Checklist of required equipment and area is attached with BPR.
  7. Check the ‘Clean label’ of required equipment is attached with BPR.

Dry syrup filling stage :

  1. Check the QA person is signed on the ‘Release for packing’.
  2. Ensure the date of ‘Lubricated Blend’ should not be exceeds the hold time.
  3. Ensure the ‘Environmental Condition Log’ is written as per Instruction given in BPR.
  4. Check the Line clearance is verified by QA.
  5. Check frequency of metal detector performance checks is as per BPR.
  6. Check speed of filling machine.
  7. Check the ‘Clean label’ of required equipment is attached with BPR
  8. Check the all inprocess checks like weight of powder, capping quality and leak test is done as per Inprocess Control Specification frequency.
  9. Check the checklist of required equipment and area is attached with BPR
  10. Ensure the quantity of labels required to packed as per BPR.
  11. Ensure the request for issuance of printed label is attached with BPR.
  12. Ensure the printed label specimen is signed and dated.
  13. Check yield reconciliation of Bottles, Caps, Labels and shipper etc.
  14. Check the yield reconciliation of powders & bottles etc.
  15. Ensure the Finished Goods transfer note and packing material Returned Note is attached with BPR.
  16. During packing process, if any process history, deviation should be attached with BPR.
  17. During review, if any discrepancy observed it must be mentioned through the QMS system.
  18. Ensure the additional pages is mentioned in BPR.
  19. Ensure the ‘Checked By- packaging’, Reviewed By- packaging’, Reviewed By- QA’ and ‘Approved By- QA’ is signed and dated.

Blister Packaging Stage :

  1. Ensure the Line clearance is verified by QA.
  2. Ensure the ‘Environmental Condition Log’ is written as per Instruction given in BPR.
  3. Ensure the date of Blend , Compression and Capsule Filling’ should not be exceeds the hold time.
  4. Ensure the change part number and packing configuration is as per BPR.
  5. Ensure the blister/carton specimen proof as per BPR and is signed and dated.
  6. Ensure the written parameter and inprocess checks like forming temperature, sealing temperature, leak test , camera challenge test etc are performed as per BPR.
  7. Ensure the pharmacode challenge test is performed as per BPR.
  8. Ensure the speed of machine is mentioned as per specified limit.
  9. Ensure the actual temperature of Bundling, is as per specified limit.
  10. Calculate the total weight if Shipper is correct within limit.
  11. Ensure the Sign & date of Weighed By, Done By and Checked By is completed.
  12. Reconciliation should be calculate as per particulars.
  13. Ensure the Finished Goods transfer note and packing material Returned Note is attached with BPR.
  14. Check the checklist of required equipment and area is attached with BPR
  15. Check the ‘Clean label’ of required equipment is attached with BPR
  16. During packing process, if any process history, deviation should be attached with BPR.
  17. During review, if any discrepancy observed it must be mentioned through the QMS system.
  18. Ensure the additional pages is mentioned in BPR.
  19. Ensure the ‘Checked By- packaging’, Reviewed By- packaging’, Reviewed By- QA’ and ‘Approved By- QA’ is signed and dated.

Related topic : https://pharmaceuticalupdates.com/2019/02/10/procedure-for-review-of-batch-manufacturing-record-bmr-or-batch-processing-record-bpr/

Conclusion :

  1. Review is a important part of during and after Manufacturing and packing operation.
  2. Any missing part in the document should be identified by the reviewer during review.
  3. Any observation identified shall be compiled before release of the batch to the market and if required deviation shall be raised in order to rectify the observation.
  4. Before release of the batch to the market both Production and Quality personnel shall ensure the completeness or closing of the documents and deviation or change control or investigation if any.

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