Issuance And Closing of Batch Manufacturing Record SOP

Standard Operating Procedure of Issuance And Closing of Batch Manufacturing Record is describe in this post.

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1.      Purpose:

1.1.   To establish a procedure for issuing BMR to production department for batch manufacturing.

2.      Scope:

2.1.   It is applicable to BMRs of all products manufactured at __ Pharmaceuticals

3.      Responsibilities:

3.1.   Production Manager

3.2.   QA Officer

3.3.   QA Incharge

4.      Procedure:

4.1.   Issuance:

4.1.1.  QAD receives BMR Requisition Note from Production Department.

4.1.2.  QAD will photocopy the requested BMR from original hard copy.

4.1.3.  QA Officer will stamp and sign the each page of whole BMR with “ISSUED” stamp (Green colored).

4.1.4.  Enter the product name, Batch No. and date of issuance in Batch No. register.

4.2.   Closing:

4.2.1.  QAD will receive completed BMR after packing of the whole batch.

4.2.2.  Returned date will be enter on Batch No. register.

4.2.3.  BMR will be reviewed by QA, QC Manager and Director.

4.2.4.  Enter the closing date in log of BMR, than keep the BMR safe and sound in record room.

5.      Review Frequency:

SOP will be reviewed at least Annually.


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