SOP on Issue of Batch Manufacturing Records for Contract Manufacturing Locations
Objective : To lay down a procedure for issue of Batch Manufacturing Records to contract manufacturing locations.
Scope : To lay down a procedure for issue of Batch Manufacturing Records to contract manufacturing locations.
Responsibility : Executive / Officer of the Quality Assurance department is responsible for the issuance of Batch Manufacturing Records. Head of Quality Assurance and Head Contract Manufacturing shall be responsible for its compliance
Procedure : Based upon the production plan, Head of Contract Manufacturing department or his designee shall submit a BMR Issue Request Form – Contract Manufacturing to the Quality Assurance Department or Quality Assurance based on the manufacturing locations for issuance of BMRs.
As per the requirement, Executive / Officer, Quality Assurance shall arrange photocopy of technical directions (manufacturing) and technical directions (packaging) for each product from the Master Formula Record.
Executive / Officer, QA shall assign a batch number to each BMR as per SOP titled ‘Batch Numbering System at Contract Manufacturing Locations’, which shall be written on all the pages of BMR and each page shall be stamped with QA Stamp (round) and initialed by Executive / Officer QA with date of issue on the weighment sheet of technical directions (manufacturing) and packaging order.
A separate series of file numbers shall be maintained for BMRs of different contract manufacturing location. Each BMR shall be assigned a 15-character file number. The file number shall consist of first three characters of BMR followed by oblique (/) and location code alphabet.
The cover of BMR file shall bear the following information:
- File number
- Product
- Batch number
- Date of manufacturing
- Date of expiry
- Pack size
- Batch size
- Market
It shall be stamped with QA stamp and initialed by Executive / Officer, QA.
All the details of the issuing BMR shall be entered in the “BMR Issuance Register – Contract Manufacturing” and ” Batch Issuance Register – Contract Manufacturing”.
The BMR shall be sent to head of contract manufacturing department or his designee and the acknowledgement of BMR receipt shall be obtained on BMR Issuance Register – Contract Manufacturing.
In case there is any change in production plan or spoilage of page/s in the BMR, the same shall be returned to the QA Department along with a request for issuance of fresh copy on “Requisition to Re-Issue a BMR – Contract Manufacturing “.
In case of spoiled pages, the re-issued page/s shall be stamped as Duplicate Copy and initialed by officer / executive-QA with QA stamp (round) on each duplicate copy.
The necessary corrections shall also be made in the Batch Issuance Register Contract Manufacturing regarding re-issued pages.