SOP on Review of Batch Manufacturing Record
Objective : To lay down a procedure for review of batch manufacturing record.
Scope : This Standard Operating Procedure is applicable for all formulation plants.
Note: The BMRs may be reviewed as per site specific SOP, if available at the respective manufacturing location.
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.
Abbreviations and Definitions
BMR :Batch Manufacturing Record; filled / unfilled regulated photocopy of Technical Directions 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 release of respective batch for sale & distribution by Head-Quality Assurance.
During the course of BMR review, Officer/Executive Quality Assurance shall ensure that each activity is correctly recorded in the relevant forms or designated space of 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 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 instruction.
The time of operation and other entries are signed and dated by the person performing & supervising the activity.
In-process parameter like weight / fill variation, average weight, thickness, diameter, hardness etc. shall be verified.
Ensure the accuracy of 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 for next operation.
Miscellaneous Checks : Confirm 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 specified limits of respective tests.
Ensure Expiry date is assigned to the product as per SOP titled : “Assigning of Manufacturing and Expiry date to the Finished Products during Manufacturing”.
Report of any discrepancy of deviation as per the SOP title “Handling of Deviations in Facility, SOPs, BMR and Specification”.
Confirm the retail price of the product, if applicable and check batch coding / over printing detail on attached specimen on relevant packaging materials.
Note : The scope of review of BMR shall not be restricted to the points given in SOP / checklist only.
Finally after review of BMR by Officer / Executive Quality Assurance, the same shall be forwarded along with ‘Checklist for BMR review and product release for sale’ to Head – Quality Assurance for authorization of product release as per SOP title “Release of Finished Goods”.