sop for Issuance retrieval and destruction of BMR and analytical records
The objective of this SOP is:
1.1 To lay down a procedure for issuance, Storage, Retrieval and Destruction of BMR and Control Records.
2.1 Officer / Executive – Quality Assurance (QA) shall be:
2.1.1. Responsible for issuing a current and approved copy of BMR with respect to BMR No., Batch No, Batch size, Manufacturing Date and Expiry Date.
2.1.2. Responsible for making entries with respect to BMR No. Batch Size, Issue Date, Mfg. Date, Exp. Date, Price in BMR Issuance Register.
2.1.3. Responsible for receipt and storage of completed BMRs & Control Records in the documentation cell for a specified period.
2.2 Officer –Production / Warehouse
2.2.1 Responsible for intimation for issuance of BMR to Quality Assurance, Receipt of BMR & submission of completed BMR on batch completion to Quality Assurance.
Head – Quality Assurance
4.1 PROCEDURE FOR ISSUANCE:
4.1.1. On receiving weighment sheet, Officer – QA will issue the BMR.
4.1.2. The Photocopy of Master Copy of BMR shall be issued by stamping “CERTIFIED COPY” on each page of BMR at the right side bottom corner.
4.1.3. Certified copy shall be signed by QA- Officer and Batch Number shall be written on each page of BMR in green ink.
4.1.4. Officer – QA shall record the issuance of BMR in BMR Issuance Register (Refer Annexure– 1)
4.1.5. The Certified copy of BMR shall submit to Production and acknowledgement shall be taken in the BMR Issuance Register.
4.2 PROCEDURE FOR STORAGE
4.2.1 Completed BMRs & analytical Records shall be stored in documentation cell after ensuring that BMR is complete in all aspects as per SOP No. A/QA/005.
4.2.2 BMRs shall be stored for the period of one year from the date of expiration of the product.
4.2.3 Analytical records shall be stored for one year from the date of expiration of the product.
4.3 RETRIEVAL OF BMRs FROM DOCUMENTATION CELL
4.3.1 BMRs from documentation cell can be issued for review or study only with written permission of Quality Assurance Manager or Quality Control Manager.
4.4 DESTRUCTION OF BMRs
4.4.1 All BMRs and analytical records due for destruction shall be taken out from documentation cell and taken to shredder.
4.4.2 All these documents shall be disposed off by shredding in shredder in presence of Quality Assurance – Officer.
Trainer — Head – Quality Assurance
Trainees — Executive / Officers QA / Production / Warehouse
Certified Copy : Head – Plant Operation
Original Copy : Head – QUALITY ASSURANCE.
Annexure – 1 : Format for BMR Issuance Register
Annexure – 2 : Schematic Diagram
ANNEXURE – 1
FORMAT FOR BMR ISSUANCE REGISTER
BMR / BMR ISSUANCE REGISTER
Product Name: Page No.:
BMR / BMR No.
ANNEXURE – 2