Saturday, November 20, 2010

Instruction For Issuance, Storage and Destruction Of BMR

1.0         Purpose      :    To provide instruction for Issuance, Storage and Destruction of BMR.

2.0         Objective    :    To provide a documented procedure for Issuance, Storage and Destruction of BMR.

3.0           Scope         :       This procedure is applicable for Issuance, Storage and Destruction of BMR.

4.0         Responsibility   :
·        Primary   : Officer – QA.
·        Secondary  : Production In-change.

5.0       Procedure   :
·        Issuance Procedure of Batch Manufacturing Record (BMR).
Ø     Issue the BMR request / issuance note from QA department.
Ø     Fill up the respective BMR details in issuance note with signature of user and send to QA for the issuance of respective BMR.
Ø     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.
Ø     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.
Ø     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.
Ø     Enter the issuance entry in BMR issuance register.
Ø     Send the controlled copy of BMR to production department.
Ø     Production personnel shall enter the required entries into BMR while manufacturing the product.
Ø     After completion of manufacturing activities, production dept. shall return the BMR to QA.
Ø     QA shall enter the necessary entry into BMR issue register and acknowledge the receipt of BMR signing in the BMR issue register.
Ø     QA personnel shall collect the certificate of analysis and other related data if any from quality control department and shall attach with BMR.
Ø     This BMR shall be placed in a folder and shall be stored at respective BMR storage room.
·        Storage Procedure of Batch Manufacturing Record (BMR).
Ø     Once the all attachments attached with BMR, BMR shall be placed in a cover.
Ø     Label the cover indicating Product Name, Batch No, Batch Size, Date of Mfg. and Date of Exp.
Ø     Seal the envelope using cello tape.
Ø     Store this envelop in respective record room.
·        Destruction Procedure of Batch Manufacturing Record (BMR).
Ø     Minimum retention period for BMR shall be 05 years.
Ø     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.
Ø     Enter the necessary entry into BMR destruction register.

6.0      Reference Document  :
v     BMR request
v     BMR issue logbook

LOG BOOK FOR BMR ISSUANCE

Sr. No.
Date of Issue
BMR issue no.
Product code
Product stage
Batch No.
Batch size in kg
Mfg. Date
Issued by QA
Received by Production






















LOG BOOK FOR BMR DESTRUCTION

               
Sr. No.
Date of Issue
BMR issue no.
Product code
Product stage
Batch No.
Batch size in kg
Mfg. Date
Exp. Date
Destruction due date
Destroyed on
Destroyed by
Checked by
Remarks





























7.0      Abbreviations:
·        QA   = Quality Assurance department
·        SOP = Standard Operating Procedure
·        QC = Quality Control
·        BMR = Batch Manufacturing Record

8.0      Copies to Distribution Sites.  :
·        QA
·        Production 

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