Review of Batch Manufacturing Record
Objective:
To lay down a procedure for the review of batch manufacturing records.
Scope:
This Standard Operating Procedure is applicable for formulation plants of a Pharma company.
Responsibility:
Officer / Executive, Quality Assurance shall be responsible for reviewing Batch Manufacturing Record.
Head – Quality Assurance shall be responsible for the implementation & compliance of this procedure.
Accountability:
The head – of Quality Assurance shall be accountable for the implementation & compliance of this procedure.
Abbreviations and Definitions:
BMR: Batch Manufacturing Record; filled/unfilled regulated photocopy of MFR along with other requisite forms/records, which reveals all the information of a batch of a product.
Procedure:
Officer / Executive, Quality Assurance deputed for BMR review shall review each BMR, prior to the release of the respective batch for sale & distribution by Head-Quality Assurance.
During the course of the BMR review, Officer/Executive Quality Assurance shall ensure that each activity is correctly recorded in the relevant forms or designated space of the Batch Manufacturing Record.
The Officer / Executive, Quality Assurance shall review the process under the following heads:
Raw Material Dispensing
Check potency calculation for active raw materials done in BMR & check whether dispensing has been done as per potency calculation.
Check entries made in weighment sheet of the Batch Manufacturing Record.
Randomly check entries of raw materials with relevant store documents attached in BMR.
Manufacturing / Packaging Operation
Ensure and confirm that each manufacturing operation is correctly recorded as defined in respective manufacturing/packaging instructions.
The time of operation and other entries are signed and dated by the person performing & supervising the activity.
In-process parameters like weight/fill variation, average weight, thickness, diameter, hardness, etc. shall be verified.
Ensure the accuracy of the packaging material used.
Test Reports
Verify that the test results are in accordance with the prevailing specification of the product/material.
The test report is signed and authorized to proceed with the next operation.
Miscellaneous Checks :
Confirm that in-process checks are being performed as per respective SOPs and recorded with correct calculations.
Correct yield is calculated and recorded in the BMR.
Confirm reconciliation of packaging material is correct.
The certificate of analysis for active raw materials / Finished product is attached & does comply with the specified limits of respective tests.
Ensure the Expiry date is assigned to the product as per SOP titled: “Assigning of Manufacturing and Expiry date to the Finished Products during Manufacturing”.
Report any discrepancy of deviation as per the SOP title “Handling of Deviations “.
Confirm the retail price of the product, if applicable, and check batch coding / overprinting detail on the attached specimen on relevant packaging materials.
Note: The scope of review of BMR shall not be restricted to the points given in the SOP/checklist only.
Finally after reviewing of BMR by Officer / Executive Quality Assurance, the same shall be forwarded along with ‘Checklist for BMR review and product release for sale’ to the Head – Quality Assurance for authorization of product release as per SOP title “Release of Finished Goods”.
Forms and Records:
Checklist for BMR review and Product release for sale – Annexure-I
Distribution:
Master Copy -Documentation Cell (QA)
Controlled Copies -Finished Goods Warehouse, Production, Quality Assurance, Quality Control, Stores.
History:
Annexure -I
Checklist for review of BMR
Checklist for Raw material Dispensing Stage
- Ensure the ‘Environmental Condition Log’ is written as per the Instructions given in BMR.
- Ensure the Line clearance is verified by QA.
- Ensure the balance calibration date and due date are recorded.
- Check the calculation of the Potency of API and verify by QA. if applicable.
- Ensure the label of ‘Dispensed Material’ is as per the ‘Bill of Material’.
- Ensure the Sign & date of Weighed By and Checked By are completed.
- Ensure the selection of the code of active material is done, if applicable.
- Quantity of material issued with respect to quantity as per ‘Bill of Material’
- Ensure the Checklist of required equipment and area is attached with BMR.
- Check the ‘Clean label’ of the required equipment is attached with BMR.
- 10. Ensure the Printout of Balance is attached, material-wise with BMR (If applicable)
Checklist for Granulation Stage
- Ensure the date of ‘Dispensed Materials’ is within the hold time.
- Ensure the ‘Weight Verification’ of all ‘Dispensed Materials’ is completed and signed prior to manufacturing.
- Ensure the ‘Environmental Condition Log’ is written as per the Instructions given in BMR.
- Check the Line clearance is verified by QA.
- Ensure the Sieve/Screen is used as per mention in the batch record.
- Calculate the total net weight of containers used for the binder as per the required quantity.
- Check the pre-lubrication and Lubrication activity is performed as per BMR.
- Check the Printout of the blending activity with the actual Start Time, End Time, and RPM.
- Ensure the calculation of the ‘Reconciliation’ of the blend is correct.
- Ensure the Sign & date of Weighed By, Done By, and Checked By is completed.
- Check the checklist of required equipment and area attached with BMR.
- Check the ‘Clean label’ of the required equipment is attached with BMR.
Checklist for Compression Stage
- Ensure the ‘Environmental Condition Log’ is written as per the Instructions given in BMR.
- Check the QA person is signed on the ‘Release for Compression’.
- Ensure the date of ‘Lubricated Blend’ should not exceed the hold time.
- Ensure the ‘Environmental Condition Log’ is written as per Instruction given in BMR.
- Check the Line clearance is verified by QA.
- Check the actual type of cam is mentioned.
- Check the written frequency of metal detector performance checks if as per BMR.
- Check the all In process is done as per In-process Control Specification frequency.
- Ensure the printout time is as per In-process checks and it should sign with a date.
- Ensure the balance calibration date and due date is recorded.
- Calculate the total net weight is written correct.
- Ensure the Sign & date of Weighed By, Done By and Checked By is completed.
- Calculate the net weight of each container is written correctly & yield reconciliation
- Check the checklist of required equipment & the ‘Clean label’ of the required equipment is attached with BMR.
Checklist for Capsule Filling Stage
- Check the QA person is signed on the ‘Release for Capsule filling’.
- Ensure the date of ‘Lubricated Blend’ should not exceed the hold time.
- Ensure the ‘Environmental Condition Log’ is written as per the Instructions given in BMR.
- Check the Line clearance is verified by QA.
- Check the frequency of metal detector performance checks as per BMR.
- Ensure the Empty Capsules Sorter Challenge test is performed as per BMR.
- Check all the In-process is done as per In-process Control Specification frequency.
- Check the printout time/Manual weight entry time as per In-process checks and it should sign with a date.
- Ensure the balance calibration date and due date are recorded.
- Ensure the Sign & date of Weighed By, Done By, and Checked By is completed.
- Calculate the net weight of each container is written correctly & yield reconciliation.
- Check the checklist of required equipment & the ‘Clean label’ of the required equipment is attached with BMR.
Checklist for Coating Stage
- Check the QA person is signed on the ‘Release for Coating’.
- Ensure the ‘Environmental Condition Log’ is written as per the Instructions given in BMR.
- Ensure the date of ‘Compression’ should not exceed the hold time.
- Ensure the actual parameters at the ‘Preparation of Suspension’ stage.
- Calculate the total net weight of coating suspension containers used for the required quantity.
- Ensure the calculation of the average weight of the core and coated tablets.
- Ensure the calculation for spray rate of coating suspension & weight gain.
- Calculating the net weight of each container is written correctly.
- Ensure the Sign & date of Weighed By, Done By, and Checked By is completed.
- Reconciliation should be calculated as per particulars
- Check the checklist of required equipment & ‘Clean label’ of the required equipment is attached with BMR.
Checklist for Inspection Stage
- Ensure the ‘Environmental Condition Log’ is written as per the Instructions given in BMR.
- Check the Line clearance is verified by QA.
- Ensure the number of defective tablets/ capsules is as per the quantity of each type of defective tablets/capsules observed.
- Calculate the net weight of each container and the total net weight is written correctly.
- Ensure the Sign & date of Weighed By, Done By, and Checked By is completed with balance calibration date
Reconciliation should be calculated as per particulars. - Check the checklist of required equipment and area is attached with BMR.
- Check the ‘Clean label’ of the required equipment is attached with BMR.
- Check for the manufacturing process, if any processing history, the deviation should be attached with BMR
- QA person should sign and date in the ‘Manufacturing Deviations’ table provided in BMR if any.
Ensure the additional pages are attached in BMR. - Ensure the ‘Checked By- production’, Reviewed By- production’, Reviewed By- QA’, and ‘Approved By- QA’ are signed and dated.
Annexure-II
CHECKLIST FOR BMR REVIEW AND PRODUCT RELEASE FOR SALE
Product Name: …………………………… Batch Number:………………………………
Batch Manufacturing Record (BMR)
-
- Batch documentation is complete and approved by a Responsible person; records are readable, unequivocal, and correct.
- Manufacturing & Packaging operations performed according to approved TD.
- All raw materials according to TD, incl. correct amounts.
- All raw materials are released prior to use.
- Cleaning of equipment/cleaning records correctly
- IPQA tests have been done according to the procedure.
- Reconciliation of packaging materials correctly.
- Any deviations reported If yes: Deviation report(s) available and closed by QA Deviation No(s): _____
- Batch documentation supports the release of the product.
Testing / Quality Control:
-
- Analytical reports are complete and approved by a responsible person(s); records readable, unequivocal and correct.
- Testing according to current authorized Spec./ STP.
- Test results are according to approved specifications.
- Any deviations/OOS results reported. If yes: Deviation/OOS report(s) available and closed by QA/QC deviation/OOS report reference No.: ____
Release for sale:
The undersigned authorized person certifies that the batch has been manufactured and tested in accordance with the requirements of the product authorization and all other requirements regarding the manufacture, quality control, and release of pharmaceutical products for sale.
