DOCUMENT OVERVIEW
What this BMR SOP covers
A Batch Manufacturing Record (BMR) documents the manufacturing history of an individual batch. This SOP describes how Production requests the record, how Quality Assurance issues an authenticated copy, and how the completed record returns to QA for review and retention.
The package contains the issuance and control procedure, a BMR requisition form and a BMR issuance and retrieval log in one editable Word document. It assigns responsibilities to Production, QA personnel and quality leadership. It does not contain a product-specific master manufacturing record or a separate detailed BMR review checklist.
How BMR issuance and retrieval works
The following overview explains the workflow in this template. Apply the approved site procedure during manufacturing.
1. Production requests the BMR+
Production prepares the requisition for the planned product and batch and sends it to QA before manufacturing. The request identifies the record required and documents the handover of that request.
2. QA prepares and authenticates the copy+
QA takes a copy of the relevant master BMR and applies the prescribed issuance stamps, signatures and dates. Batch identification is entered on the designated pages so the issued record can be traced to its batch.
3. QA records the issue to Production+
QA enters the handover in the issuance and retrieval log and obtains the receiving signature. Production uses the authenticated record to document the batch activity.
4. Production returns the completed record+
After batch processing, Production submits the completed BMR and associated records to QA. The return is recorded in the log with the applicable handover signatures.
5. QA reviews and retains the record+
QA personnel and the QA head or designee review the completed BMR under the assigned responsibilities. The site must confirm its applicable retention rules and assess the source procedure’s API/retest and QR-label provisions before controlled use.
What is included in the BMR SOP package
BMR issuance and control procedure
The procedure covers requisition, copy authentication, batch identification, handover, return, review responsibilities and retention.
BMR requisition form
Records the product, stage, batch number and request date, with requested-by and received-by signatures and dates.
BMR issuance and retrieval log
Connects the issue and return of the record through product and batch details, dates, handover signatures, return details and remarks.