Bmr preperation

for you

1. Facilitators: -
Dr. Vishal Kumar Gupta,
Asst Professor,
Dept. of Pharmaceutics,
JSS college of pharmacy,
Mysore.
Submitted by: -
Ram Mohan S.R.
1st M.Pharm
Pharmaceutical Quality Assurance
JSS college of pharmacy
Mysore
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2. Batch manufacturing records should be prepared for
each intermediate and API/formulation and should
include complete information relating to the
manufacturing and control of each batch.
The batch manufacturing record should be checked
before issuance to assure that it is the correct version
and a legible accurate reproduction of the appropriate
master production instruction.
Pharmaceutical Quality Assurance, Dept of Pharmaceutics 2

3. Before any processing begins, a check should be
performed and recorded to ensure that the equipment
and workstation are clear of previous products,
documents, or materials not required for the planned
process and that the equipment is clean and suitable
for use.
These records should be numbered with a unique
batch or identification number and dated and signed
when issued.
Pharmaceutical Quality Assurance, Dept of Pharmaceutics 3
Contd……

4. The “Batch Manufacturing Record” is the
necessary quality and GMP documentation for
tracing the complete cycle of manufacturing
batch or lot
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Pharmaceutical Quality Assurance, Dept of Pharmaceutics

5. Documentation of completion of each
significant step in the BMR should include:
•Dates and, when appropriate, times
•Identity of major equipment used (e.g., reactors,
driers, mills, etc.)
•Actual results recorded for critical process
parameters
•Any sampling performed
Pharmaceutical Quality Assurance, Dept of Pharmaceutics 5

6. •Specific identification of each batch, including weights,
measures, and batch numbers of raw materials,
intermediates, or any reprocessed materials used during
manufacturing
•Signatures of the persons performing and directly
supervising or checking each critical step in the
operation
•In-process and laboratory test results
•Actual yield at appropriate phases or times
Pharmaceutical Quality Assurance, Dept of Pharmaceutics 6

7. •Description of packaging and label
•Representative label (commercial supply)
•Any deviation noted, its evaluation, and investigation
conducted (if appropriate) or reference to that
investigation (if stored separately).
•A decision for the release or rejection of the batch, with
the date and signature of the person responsible for the
decision.
•Results of release testing
Pharmaceutical Quality Assurance, Dept of Pharmaceutics 7

8. •Production and quality control records should be
reviewed as part of the approval process of batch
release.
•Any divergence or failure of a batch to meet its
specifications should be thoroughly investigated.
•The investigation should, if necessary, extend to
other batches of the same product and other products
that may have been associated with the specific
failure or discrepancy.
Pharmaceutical Quality Assurance, Dept of Pharmaceutics 8

9. Responsibility:-
Primary:Officer–QA/Officer–QC/Officer-Production
Secondary:Manager-QA/Manager-QC/Manager-Production
Pharmaceutical Quality Assurance, Dept of Pharmaceutics 9

10. Issue of batch manufacturing record
( by Quality Assurance)
1)BasedonProductionplanning,productionmanager
shalldecideontheproductandthenumberofbatches
tobeproducedinthemonth.
2)Productionsupervisorshallraisetherequisitionforthe
batchestobetakenfortheweekandforwarditto
QualityAssurance.
Pharmaceutical Quality Assurance, Dept of Pharmaceutics 10

11. 3)OnreceiptofBatchManufacturingRecordissue
requisitionQApersonnelwillverifythedetails
enteredintherequisitionform.
4)AphotocopyoftheMASTERCOPYofthe
requiredProductBatchManufacturingRecord
willbetaken.
5)AllthepagesofthephotocopiedsheetofProduct
BatchManufacturingRecordshallbesignedand
datedbyQAPersonnel.
Pharmaceutical Quality Assurance, Dept of Pharmaceutics 11

12. 6)CheckforthecorrectnessoftheBatchnumberby
verifyingtheBMRregister.
7)EnterthedetailsofDate,Product,BatchNo,Batch
size,ManufacturingDate,ExpiryDateandissued
bydetailsintheBMRregister.
8)Checkandallotexpirydatebyreferringtomaster
listofproductshelflife.
Pharmaceutical Quality Assurance, Dept of Pharmaceutics 12

13. 9)Enterthebatchno.OnallthepagesoftheBMRandget
itauthorizedbyQAmanagerorinabsencebyQA
executiveorQAofficer.
10)InsertthesignedbatchrecordinaBMRcoverandenter
thedetailsofproductname,batchnumber,batchsize.
Manufacturingdateandexpirydate.
11)Batchrecordalongwiththebatchrecordregistershallbe
senttoproduction,theproductionpersonreceivingthe
batchrecordshouldsignonthebatchrecordregisterto
acknowledgethereceiptofbatchrecord.
12) QA person who has issued Batch Record shall sign the
“issued by” on batch record issue requisition sheet and file the
same for future reference.
Pharmaceutical Quality Assurance, Dept of Pharmaceutics 13

14. Entry of Batch Manufacturing Records
(By Production Personnel)
1)On receipt of BMR Production Manager/Dy.
production Manager shall check the BMR and sign on
the first page.
2)The calculation sheet should be forwarded to stores for
entry of the relevant AR Nos., quantity and assay
value.
Pharmaceutical Quality Assurance, Dept of Pharmaceutics 14

15. 3)After the relevant entry store forward the sheet to
production department where production chemist
fill equipment status detail where line clearance
status and ECR No. should be entered for each
equipment.
4)Now operator fill the next form of process to be
carried out for particular reactor in which starting
and ending time should be entered and finally sign
by operator and checked by in-charge.
Pharmaceutical Quality Assurance, Dept of Pharmaceutics 15

16. 5)After completion of every reaction in each of the
particular reactor intermediate should be send to QC
Lab. for checking of completion of reaction, LOD etc.
6)After final product obtained send the request to QC
for complete analysis of the product and send the
analytical report.
7)Fill all remaining entry and attach all analytical report.
8)BMR should be then send to QA department for
Review
Pharmaceutical Quality Assurance, Dept of Pharmaceutics 16

17. Review and Control of Batch Manufacturing
Records
( by Quality Assurance)
1)Batch No. should be checked by Quality assurance
department.
2)Review the Analytical report of all raw materials
attached with BMR and check the A.R. No.
3)Review the Equipment Cleaning Record for each
equipment and relevance of line clearance by QC.
Pharmaceutical Quality Assurance, Dept of Pharmaceutics 17

18. 4)Reviewthedeviationinprocesswhichis
predefined.
5)Ifanydeviationpresentchangedeviationreportof
processshouldbethere.Reviewthereportof
changeindeviationanditssignificanceinthe
process.
6)Checkthequantityofsolventrecoveredinthe
process.Recoveryshouldbeproperandcomplete.
7)Wetmaterialpackingrecordshouldbereviewed.
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19. 8)Drying record as well as dry material packing record
should be checked and reviewed.
9)Check the analytical report of finished product
generated by QC department.
10)Finally attach the review report with specific
number given by QA department duly dated and
singed by QA manager.
11)If everything is fine then pass the batch and allow it
for dispatch
Pharmaceutical Quality Assurance, Dept of Pharmaceutics 19

20. 12)SendthisrecordinsafecustodyofQuality
Assurancedepartment.
13)IfanybodyneedsthecopyofBMRitshouldbe
givenasacontrolcopywithpermissionofQA
Manager.
14)EveryBMRshouldbesavedforfiveyearsfrom
manufacturingandafterthatitshouldbedestroyed
asperSOP.
Pharmaceutical Quality Assurance, Dept of Pharmaceutics 20

21. Batch Manufacturing Record
Attachments
Responsibility:
Primary:ProductionChemist.
Secondary:ProductionOfficer.
Pharmaceutical Quality Assurance, Dept of Pharmaceutics 21

22. Following attachments required to be attached to Batch
Manufacturing Record before submitting the completed
BMR to Quality Assurance.
•Equipmentcleanrecordstatuslabel.
•Equipmentcleanrecord.
•Rawmaterialsdispensedweighingslip.
•Intermediaterawmaterialsealed.
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23. •Transfer note for finished goods to F.G. store.
•Raw material issue order (P.R).
•IPQC-In Process Test Request Cum Report.
•Excess material requisition (S.R.).
•Deviation note if any.
•Certificate Of Analysis (COA).
•Finish product dispatch data.
Pharmaceutical Quality Assurance, Dept of Pharmaceutics 23

24. BMR draft
Pharmaceutical Quality Assurance, Dept of Pharmaceutics 24

25. Pharmaceutical Quality Assurance, Dept of Pharmaceutics 25
D.H. SHAH, “QA Manual”,1/e,S/p 2010,
Business Horizons, page no 174-176
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26. Pharmaceutical Quality Assurance, Dept of Pharmaceutics 26