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- Production Manager- QC
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.
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