Procedure for Review of Batch Manufacturing Record (BMR) or Batch Processing Record (BPR)

What is Batch Manufacturing Record (BMR) or Batch Processing Record (BPR) :

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

Procedure for review of BMR or BPR :

Raw material Dispensing Stage:

  1. Ensure the ‘Environmental Condition Log’ is written as per Instruction given in BMR.
  2. Ensure the Line clearance is verified by QA.
  3. Ensure the balance calibration date and due date is recorded.
  4. Check the calculation of Potency of API and verified by QA.if applicable.
  5. Ensure the label of ‘Dispensed Material’ is as per ‘Bill of Material’.  
  6. Ensure the Sign & date of Weighed By and Checked By is completed.
  7. Ensure the selection of code of active material is done, if applicable.
  8. Quantity of material issued with respect to quantity as per ‘Bill of Material’. 
  9. Ensure the Checklist of required equipment and area is attached with BMR.
  10. Check the ‘Clean label’ of required equipment is attached with BMR.
  11. Ensure the Printout of  Balance is attached, material wise with BMR (If applicable)

Granulation Stage :

  1. Ensure the date of ‘Dispensed Materials’ is within the hold time.
  2. Ensure the ‘Weight Verification’ of all ‘Dispensed Materials’ is completed and signed prior to manufacturing.  
  3. Ensure the ‘Environmental Condition Log’ is written as per Instruction given in BMR.
  4. Check the Line clearance is verified by QA.
  5. Ensure the Sieve/Screen is used as per mention in the batch record
  6. Calculate the total net weight of containers used for binder is as per required quantity.
  7. Check the pre-lubrication and Lubrication activity is performed as per BMR.
  8. Check the Printout of blending activity with actual Start Time, End Time and RPM.
  9. Ensure the calculation of ‘Reconciliation’ of blend is correct.
  10. Ensure the Sign & date of Weighed By, Done By and Checked By is completed.
  11. Check the checklist of required equipment and area is attached with BMR.
  12. Check the ‘Clean label’ of required equipment is attached with BMR.

Compression Stage :

  1. Ensure the ‘Environmental Condition Log’ is written as per Instruction given in BMR.
  2. Check the QA person is signed on the ‘Release for Compression’.
  3. Ensure the date of ‘Lubricated Blend’ should not be exceeds the hold time.
  4. Ensure the ‘Environmental Condition Log’ is written as per Instruction given in BMR.
  5. Check the Line clearance is verified by QA.
  6. Check the actual type of cam is mentioned.
  7. Check the written frequency of metal detector performance checks if as per BMR.
  8. Check the all In process is done as per In process Control Specification frequency.
  9. Ensure the printout time as per In process checks and it should sign with date.
  10. Ensure the balance calibration date and due date is recorded.
  11. Calculate the total net weight is written correct.
  12. Ensure the Sign & date of Weighed By, Done By and Checked By is completed.
  13. Calculate the net weight of each container is written correct
    & yield reconciliation
  14. Check the checklist of required equipment & ‘Clean label’ of required equipment is attached with BMR.

Capsule Filling Stage :

  1. Check the QA person is signed on the ‘Release for Capsule filling’.
  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 BMR.
  4. Check the Line clearance is verified by QA.
  5. Check frequency of metal detector performance checks is as per BMR.
  6. Ensure the Empty Capsules Sorter Challenge test is performed as per BMR.
  7. Check all the In process is done as per In process Control Specification frequency.
  8. Check the printout time/Manual weight entry time as per In process checks and it should sign with date.
  9. Ensure the balance calibration date and due date is recorded.
  10. Ensure the Sign & date of Weighed By, Done By and Checked By is completed.
  11. Calculate the net weight of each container is written correct & yield reconciliation.
  12. Check the checklist of required equipment & ‘Clean label’ of required equipment is attached with BMR.

Coating Stage :

  1. Check the QA person is signed on the ‘Release for Coating’.
  2. Ensure the ‘Environmental Condition Log’ is written as per Instruction given in BMR.
  3. Ensure the date of ‘Compression’ should not be exceeds the hold time.
  4. Ensure the actual parameters at ‘Preparation of Suspension’ stage.
  5. Calculate the total net weight of coating suspension containers used for required quantity.
  6. Ensure the calculation for average weight of core and coated tablets.
  7. Ensure the calculation for spray rate of coating suspension & weight gain.
  8. Calculate the net weight of each container is written correct.
  9. Ensure the Sign & date of Weighed By, Done By and Checked By is completed.
  10. Reconciliation should be calculate as per particulars
  11. Check the checklist of required equipment & ‘Clean label’ of required equipment is attached with BMR.

Inspection Stage :

  1. Ensure the ‘Environmental Condition Log’ is written as per Instruction given in BMR.
  2. Check the Line clearance is verified by QA.
  3. Ensure the quantity of defected tablets/ capsules is as per quantity of each type of defective tablets/capsules observed.
  4. Calculate the net weight of each container and total net weight is written correct.
  5. Ensure the Sign & date of Weighed By, Done By and Checked By is completed with balance calibration date
  6. Reconciliation should be calculate as per particulars.
  7. Check the checklist of required equipment and area is attached with BMR.
  8. Check the ‘Clean label’ of required equipment is attached with BMR.
  9. Check for manufacturing process, if any process history, deviation should be attached with BMR.
  10. QA person should sign and date in ‘Manufacturing Deviations’ table provided in BMR if any.
  11. Ensure the additional pages are attached in BMR.
  12. Ensure the ‘Checked By- production’, Reviewed By- production’, Reviewed By- QA’ and ‘Approved By- QA’ is signed and dated.

Conclusion :

These above mentioned documents shall be reviewed by both production and Quality Assurance step wise i.e With the completion of the step wise activities the documents shall be completed simultaneously and if the documents are incomplete then Production as well as Quality Assurance shall not move to the next step or activity .

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