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

1 comment:

  1. If you make an effort marketing automation to understand them.
    I enployed direct response marketing, you need to create awareness about
    your goods, service or brand. Space the mailings out just far enough so that
    they do not put enough effort to their marketing strategies.
    When money iss tight, you want to save on postage for
    presorted and automation first class and standard rate mail.


    Also visit my web-site CATI

    ReplyDelete

Related Posts Plugin for WordPress, Blogger...
Subscribe to Quality Assurance and GMP by Email