Issuance Procedure of Batch Manufacturing Record (BMR):
Issue the BMR request / issuance note from QA department.
Fill up the respective BMR details in issuance note with signature of user and send to QA for the issuance of respective BMR.
On receipt of BMR issuance request intimation / note from production department, QA shall enter the issuance entry in BMR issue register/ logbook and assigned the BMR issuance number then, photocopy the required copy of respective product BMR from the master copy of BMR.
QA personnel shall enter the information related to Batch like Batch Number, Product Stage, Manufacturing Date, Expiry Date, Batch Quantity, and BMR issue number to photocopy of BMR.
Put the stamp of CONTROLLED COPY in Blue Ink on copy of BMR, sign it with date of QA personnel in Black Ink on each page of BMR.
Enter the issuance entry in BMR issuance register.
Send the controlled copy of BMR to production department.
Production personnel shall enter the required entries into BMR while manufacturing the product.
After completion of manufacturing activities, production dept. shall return the BMR to QA.
QA shall enter the necessary entry into BMR issue register and acknowledge the receipt of BMR signing in the BMR issue register.
QA personnel shall collect the certificate of analysis and other related data if any from quality control department and shall attach with BMR.
This BMR shall be placed in a folder and shall be stored at respective BMR storage room.
Storage Procedure of Batch Manufacturing Record (BMR)
Once the all attachments attached with BMR, BMR shall be placed in a cover.
Label the cover indicating Product Name, Batch No, Batch Size, Date of Mfg. and Date of Exp.
Seal the envelope using cello tape.
Store this envelop in respective record room.
Review and control of batch manufacturing record by Quality Assurance
Batch No. should be checked by Quality assurance department.
Review the Analytical report of all raw materials attached with BMR and check the A.R. No.
Review the Equipment Cleaning Record for each equipment and relevance of line clearance by QC.
Review the deviation in process which is predefined.
If any deviation present change deviation report of process should be there. Review the report of change in deviation and its significance in the process.
Check the quantity of solvent recovered in the process. Recovery should be proper and complete.
Wet material packing record should be reviewed.
Drying record as well as dry material packing record should be checked and reviewed.
Check the Analytical report of finished product generated by Q C Department.
Finally attach the review report with specific number given by QA department duly dated and singed by QA manager.
If everything is fine then pass the batch and allow it for dispatch.
Send this record in safe custody of Quality Assurance department.
If anybody needs the copy of BMR it should be given as a control copy with permission of QA Manager.
Every BMR should be saved for five years from manufacturing and after that it should be destroyed as per SOP.
Destruction Procedure of Batch Manufacturing Record (BMR):
Minimum retention period for BMR shall be 05 years.
After expiry of retention period, QA shall confirm from corporate QA and once the confirmation received about the destruction of BMR, QA can destruct the BMR by shredding.
Enter the necessary entry into BMR destruction register.