Wednesday, November 24, 2010

Batch Manufacturing Record Review

1.0        Purpose   :    To define the salient points to be checked by QA during batch record review.

2.0       Objective:   To provide a documented procedure for points to be checked by QA during batch record review.

3.0       Scope       : To assign individual responsibilities to QA and Production with regard to proper entries and completion of batch records in time to ensure batch product release.

4.0      Responsibility  :
·        Primary: Officer–QA / Officer–QC/ Officer-Production
·        Secondary: Manager-QA/ Manager- QC/ Manager- Production   

5.0       Procedure :
·          General Checks
Ø      Records are error free, tidy, legible and accurate.
Ø      Good quality of photocopy.
Ø      The timings of each process is sequential with procedure in BMR.
Ø      Any overwriting/cancellation of entry should be signed by responsible officer.
Ø      Any deviation in process should be mentioned in batch summary sheet. QA to ascertain impact on product quality at the time of review before product release.
·          Work order
Ø      Duly authorized & signed.
Ø      Item code/AR No. filled against each item.
Ø      Correct calculation of gross/tare/net weight.
Ø      Reconcile any excess issues/returns in work order.
Ø      Ensure each item issued has two signatures of weighed by & checked by.
Ø      Ensure batch material issue/receipt, signature of responsible officers.
·          BMR Checks
Ø      Cleanliness record is entered for both equipment and areas.
ü      Equipment code numbers.
ü      Previous product details.
ü      Cleanliness checked by signature
Ø      Line clearance certification for all operations signature of Q.A.
Ø      Operation timings and name of operators are entered.
Ø      Ensure critical operations are counter checked by second person.
Ø      Verify proper timings of in - process control.
Ø      Input/Output materials reconciliation Yield of final product at each stage is within limits.
Ø      Check for proper QC reports.
Ø      Check batch summary sheet for deviation recording and authorization.
·          BMR
Ø      Work Order sheet: Qty Std. / Qty issued / checked by Ensure the individual key material qty, AR Nos. of all packing materials.
Note: The complete batch record after review and corrections will be approved by quality assurance. These records will be in safe custody of quality assurance.

6.0      Reference Document :      Not applicable

7.0      Abbreviations :
·        QA   = Quality Assurance department
·        QC = Quality Control
·        BMR = Batch Manufacturing Report
·        AR No. = Analytical Report Number


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  2. How can I check the details that u addressed above

  3. As a batch record reviewer there is a problem that is verification of gmp possible only with review of batch record, plz advise

  4. There is no reference document for batch record review how can I release the batch


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