SOP Title: Procedure for Issuance of BMR and BPR
- Objective:
This SOP outlines the procedure for issue of BMR/ BPR to Production Department.
- Scope:
This SOP is applicable to the production Department.
- Responsibility:
Plant Head : Responsible for planning of production activity.
HOD Production : Responsible for execution plan and issuing the manufacturing schedule to QA department.
QA Department : Responsible for issue of BMR/ BPR according to the manufacturing schedule.
- Accountability: Head Head
- Procedure:
- Definitions:
- QA Associate: Officer, Executive of Quality Assurance Department or any personnel trained to perform duties as per this SOP.
- Production Associate: Officer, Executive of Quality Assurance Department or any personnel trained to perform duties as per this SOP.
- Procedure:
| 5.2.1 | Details of manufacturing schedule shall be given to QA Department on monthly basis. | |
| 5.2.2 | Based on manufacturing schedule request for requirement of BMR and BPR shall be sent to QA Department 2 days before the date of requirement. | |
| 5.2.3 | QA shall review the request for B. No., Mfg. Date, Exp. Date, B. Size etc. | |
| 5.2.4
|
As per the manufacturing schedule, BMRs are to be issued to the Production Department 72 hours in advance. | |
| 5.2.5 | Enter the batch details such as Batch number, Manufacturing date, Expiry date on the BMR/ BPR. | |
| 5.2.6 | Enter all the details in the BMR/ BPR issue register handover the BMR/ BPR and issue register to Production Head. | |
| 5.2.7 | In case of requirement of extra pages, the head Production shall issue a requisition to QA Department requesting for issue of additional pages with justification. | |
| 5.2.8 | On receipt of such request, QA shall issue the requested pages and file the requisition in the BMR/ BPR issue register. | |
| 5.2.9 | In case of cancellation of batch return the BMR/ BPR to QA Department along with a note stating the reason for returning the BMR/ BPR. |
- Abbreviation:
| Abbreviation | Expansion |
| QAP | Quality Assurance Procedure |
| QAD | Quality Assurance department |
| QA | Quality Assurance |
| BMR | Batch Manufacturing Records |
| BPR | Batch Packing Records |
| SOP | Standard Operating Procedure |
| HOD | Head Of Department |
*Note – Ready to use SOP available in “DOWNLOAD” Section.