Issuance And Closing of Batch Manufacturing Record SOP



Issuance And Closing of Batch Manufacturing Record SOP


1.0   PURPOSE:

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

2.0    SCOPE:


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

3.0   RESPONSIBILITY:


3.1.      Production Manager
3.2.      QA Officer
3.3.      QA Incharge


4.0    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 Log of BMR.
4.1.5.   Production department will receive the BMR and gives the receiving signature on Log Book of BMR.
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 Log book of BMR Records.
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.

5.0    REVIEW FREQUENCY:

SOP will be reviewed at least Annually.




EVIDENCES OF RECORDS & REFERENCES
Log of BMR Records (Register)
FORMAL KPIs (Key Performance Indicators)
BMR Retrieval time
GENERAL RISKS
CONTROL   MEASURES

CUSTODIAN
Risks
Impact
Issuance of BMR without approved stamp, documents is not controlled
Documents can be misused
Follow the SOP for while issuing BMR






QA Officer/ QA Manager
Wrong BMR issued, e.g. Evolet tab 250mg instead of Evolet tab 500mg.
Manufacturing will be compromised
Always take special care while issuing BMR of 2 different strength/dosage form with same name
BMR Closed and kept in record room without entering in log book
BMR will not be retrievable if needed in future
Closing must be done after entering in log book


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