sop for Issuance retrieval and destruction of BMR and analytical records

 

sop for Issuance retrieval and destruction of BMR and analytical records

 

1.0 OBJECTIVE

The objective of this SOP is:
1.1 To lay down a procedure for issuance, Storage, Retrieval and Destruction of BMR and Control Records.

2.0 RESPONSIBILITY

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.

3.0. ACCOUNTABILITY:

Head – Quality Assurance

4.0. PROCEDURE:

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.

 

5.0 TRAINING:

Trainer — Head – Quality Assurance
Trainees — Executive / Officers QA / Production / Warehouse
6.0. DISTRIBUTION:

Certified Copy : Head – Plant Operation
Original Copy : Head – QUALITY ASSURANCE.

7.0 ANNEXURES:

Annexure – 1 : Format for BMR Issuance Register
Annexure – 2 : Schematic Diagram

8.0 REFERENCE:

In-house

ANNEXURE – 1
FORMAT FOR BMR ISSUANCE REGISTER

BMR / BMR ISSUANCE REGISTER

Product Name:                                                                                                                                                        Page No.:

Sr. No.

Date

Batch No.

BMR / BMR No.

Batch Size

Price

Mfg. Date

Expiry Date

Issued By

Received By

Remark

 

ANNEXURE – 2
SCHEMATIC DIAGRAM

 

Online Rejection in parenteral

Receipt of Batch from Production to Packing Department

sop for for Spillage Handling in parenteral area

sop for calibration of vessels with dipstick

sop for Cleaning of Bins and Containers

cip of mixing vessel and holding vessel

SOP FOR BATCH MANUFACTURING

sop for placebo batch

sop for Cleaning of Ampoule Filling and Sealing Machine

sop for Fogging in Sterile and Non Sterile Area

sop for for Filtration of Bulk Solution

sop for fumigation in production area

sop for post cleaning after media fill

sop for cip of mixing vessel mixing mobile vessel and holding vessel

sop for De-Bagging of Three Piece Vial Dropper Caps

sop for calibration and verification of check weigher

sop for Batch number and Manufacturing and Expiry Date Coding System

sop for Sanitization of Seals

standard operating procedure machine history file

sop for operation and cleaning of Hand coder

sop for Cleaning and Handling and Silicone Tubes

sop on operation and cleaning of coating pan

sop for Operation of cleaning of pipe lines

Sop for equipment assembly

sop for operation of capsule loading machine semi automatic

sop for Machine operation capsule inspection and polishing machine

Sop for issue of material

Sop batch demarcation and batch coding

sop for material receipts

sop for monitoring of reprocessing of products

sop for in-process control on liquids orals

sop for in process controls on tablets capsules packaging line

sop for Issuance retrieval and destruction of BMR and analytical records

sop for in process controls during granulation compression coating inspection

sop for Cleaning of Blister packing machine

sop for for charge hand over between the shifts

Performance requalification report of visual inspectors

sop for Cleaning and operation of ROPP caps inspection table

sop for usage and destruction of filter pad and cartridge filter

sop for cleaning and storage of transfer pipe

sop for Cleaning and operation of labeling machine

Cleaning and operation of the mono block filling and sealing machine

sop for Cleaning and operation of empty bottle inspection table

sop for Cleaning and operation of filter press

sop for cleaning and operation of liquid transfer pump and line

sop for cleaning and operation of storage vessels

sop for cleaning and operation of sugar syrup manufacturing vessel

sop for cleaning issuance and retrieval of accessories and change parts

sop for Cleaning and operation of visual inspection conveyor belt

sop for Cleaning and operation of spray gun and assemble

sop for Fogging in Aseptic and Non Aseptic Area

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