BATCH RECORD REVIEW SOP

1.0 PURPOSE :
To define the salient points to be checked by QA during batch record review.
2.0 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.
3.0 RESPONSIBILITY :
Q.A.Manager, Production manager, Q.C. Manager
3.1 The responsibility to ensure batch records are completed and forwarded to QA for review is with Production.
3.2 The responsibility to ensure review of batch records and release of batch Product is with Quality Assurance.
4.0 PROCEDURE :
4.1 General Checks
4.1.1 Records are error free, tidy, legible and accurate.
4.1.2 Good quality of photocopy.
4.1.3 The timings of each process is sequential with procedure in BMR.
4.1.4 Any overwriting/cancellation of entry should be signed by responsible officer.
4.1.5 Any deviation in process should be mentioned in batch summary sheet. QA to ascertain impacton product quality at the time of review before product release.
4.2 Work order
4.2.1 Duly authorised & signed.
4.2.2 Item code/AR Nos filled against each item.
4.2.3 Correct calculation of gross/tare/net.weight
4.2.4 Reconcile any excess issues/returns in work order
4.2.5 Ensure each item issued has two signatures of weighed by & checked by.
4.2.6 Ensure batch material issue/receipt, signature of responsible officers.
4.3 BMR / BPR checks
4.3.1 Cleanliness record is entered for both equipment and areas.
4.3.1.1 Equipment code numbers
4.3.1.2 Previous product details
4.3.1.3 Cleanliness checked by signature
4.3.2 Line clearance certification for all operations signature of Q.A
4.3.3 Operation timings and name of operators are entered.
4.3.4 Ensure critical operations are counter checked by second person.
4.3.5 Verify proper timings of in - process control.
4.3.6 Input/Output materials reconciliation Vield of final product at each stage is within limits.
4.3.7 Check for proper QC reports.
Eg: T.I.S. T.R.F. PRRF are attached to BMR/BPR
4.3.8 Check over printed details of printed specimen against notation in BPR.
4.3.9 Check batch summary sheet for deviation recording and authorisation.
4.4 BPR
4.4.1 Work Order sheet : Qty Std. / Qty issued / Checked by
Ensure the individual key material qty
AR Nos. of all packing materials.
4.4.2 Packing operation sheet
4.4.2.1 Inprocess checks are done as per frequency mentioned in BPR.
4.4.2.2 Printed packaging materials details as per BPR.
4.4.2.3 Materials usage reconciliation data
4.4.2.4 Hence clearance in packing / overprinting
4.4.2.5 Final Yield analysis
4.4.2.6 Sequence timings should be checked
4.4.3 PRRF to be checked with QC report
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.