SOP For review nd reconciliation of BMR is described in this post which you can follow in the section of the Quality Assurance Department.

OBJECTIVE

This procedure has been established to provide guidelines to be followed for reviewing Batch Manufacturing Records before releasing a product for marketing.

SCOPE

This procedure is applicable to the Quality Assurance Department.

RESPONSIBILTY

QA Officer

ACCOUNTABILITY

Manager Quality Assurance

PROCEDURE

The Batch Manufacturing Record is a summary of all required Production and Quality Control records required to be submitted, reviewed and completed as part of release of product. No product will be released until a Batch Manufacturing Record is completed.

The Q.A. Department is responsible for ensuring the completion of all records in accordance with check list for enclosures (given on the Batch Manufacturing Record envelop). It includes, Manufacturing Order (MO), Packing order (PO), Raw material dispensing tags, Graphs, QC release labels, printed packaging components Specimens (Label, Carton),additional issue reports, additional return reports and FGRNs. These must be duly completed and signed by the concerned authorities.

The manufacturing documents will be checked by Production officer while packaging documents will be checked by concerned packing officer.

Production officer shall calculate all required yields at various stages of production i.e. bulk, filling, compression and packaging.

Reconciliation should be performed to determine any gain or loss at the required stages.

The production officer deputed for documentation in Production Department will compile the batch documents of both manufacturing and packaging and will check thoroughly to ensure the presence of all enclosures and submit this to Production Manager for final checking.

After compilation/ checking the Batch Manufacturing Record will be forwarded to Q.A. Department.

QA officer under the supervision of QAM will thoroughly check the Batch Manufacturing Record or the presence of listed documents, yield, reconciliation of packaging materials and product step wise signature on BMR. 

Any incomplete / incorrect information observed during Batch Manufacturing Record review will be given in writing to the concerned officer with a copy to Production Manager and Q.A. Manager.

Over-writing, use of Blanco (correction fluid) or any other means of erasing/ masking is not allowed. All corrections should be made by cutting the original entry in such a manner that the original entry is clearly visible and all the corrections must be initialed.

In case of any changes in any part of batch documents, approval should be taken from the Production Manager and Q.A. Manager.

QAM will recalculate all yields at various stages of production i.e. Bulk, filling / compression and packaging and determine if reconciliation is within acceptable limits.

In case of yield variance beyond acceptable limits, reasons for variation for yield must be recorded and signed by the Production Manager.

After thorough audit of Batch Manufacturing Record by the QAI the batch document is initialed and stamped with “Checked” on the check list for envelops and submitted to QAM for final checking and release of the batch.

The completed Batch Manufacturing Record is then stored, after entering in the BMR Audit Record. This record must include the following parameters.

Product name

Batch no.

Mfg. date

Complete date

Received in QA by/date/time

Final audit date

Status/remarks/reason for delay

The Batch Manufacturing Record should be maintained for one year after expiry of the product. After this period Batch Manufacturing Record should be incinerated.