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