BMR And MFR

BMR AND MFR

1. Presented by:
Mr. Akshay. S. Dhole
M. Pharm-I Year
Guided by:
Dr. Sanjeevani. R. Desai.
(Associate Professor)
Department of Quality Assurance
Vasantidevi Patil Institute of
Pharmacy, Kodoli

2. •What is document?
•Types of documentation.
•BMR
•MFR

3. Document is a paper that provides information
especially of an official or legal nature, written
report or record
Documentation: It is method of preparing written
material which describes the process in terms of
specification

4. BMR (Batch Manufacturing Record)
MFR (Master Formula Record)

5. The"BatchManufacturingRecord"isthe
necessaryqualityandGMPdocumentationfor
tracingthecompletecycleofmanufacturingbatch
orlot.
Thebatchmanufacturingrecordshouldbe
checkedbeforeissuancetoassurethatitisthe
correctversionandalegibleaccuratereproduction
oftheappropriatemasterproductioninstruction.

6. Beforeanyprocessingbegins,acheckshouldbe
performedandrecordedtoensurethattheequipment
andworkstationareclearofpreviousproducts,
documents,ormaterialsnotrequiredfortheplanned
equipmentiscleanandsuitableforuse.
Theserecordsshouldbenumberedwithaunique
batchoridentificationnumberanddatedandsigned
whenissued.

7. BMR CONTENT :-
Nameoftheproduct
Strength
MFRno:-masterformularecord
BMRno:
Signed&issuedbyQA
Signedforcompletionbyproduction
Billofmaterials:Itisalistofallrawmaterial
ingredientsthatarerequiredinvolvingmorematerials
whichdonotappearinthefinalproduct.

8. A good BMR format should contain following parts:
1.Batchrecord:FirstpageoftheBMRhasallrecords
aboutthebatchasbatchno.,batchsize,composition
MFR,weightofdrugshelflife,storagecondition,
manufacturingdate,expirydate.

9. 2.Generalinstructionformfg:Healthandsafety
instructiontotheoperationandbefollowedduring
themfgprocessregardingthematerialand
equipmentusedduringmfg.

10. 3.Equipmentcleaningrecord:Checklistofthe
cleaningofallequipmentisprepared.Thoseareused
inmanufacturingofthebatchincludingtheprevious
productbatchanddateofcleaning.

11. 4.Billsofmaterials:listoftherawmaterialsshould
havethequantityofthematerialwiththatARnumber.
WeightofthematerialshouldbeverifiedbyQA.

12. 5.ManufacturingProcess:-Shouldbewrittenstepby
stepineasylanguage.Milling,Shifting,Drying,
Compression,CoatingandPackinghavingall
instructionwithprocesstimeshouldbewritten.

14. 6.Yield:Yieldofbatchshouldbecalculatedattheendof
everystagetocalculatetheprocessloss.Finalyield
shouldbecalculatedattheendofmanufacturingthat
shouldnotbelessthan99%.

15. 7.Abbreviations:listofusedindocumentshouldbe
madetounderstandtheBMReasily.
8.Historyofchanges:Attheendofdocumentshould
havealistofthechangesinthedocumentincluding
therevisionno.anddateofchange.

16. Documentationofcompletionofeachsignificantstep
intheBMRshouldinclude:
Specificidentificationofeachbatch,including
weights,measures,andbatchnumbersofraw
materials,intermediates,oranyreprocessedmaterials
usedduringmanufacturing.
Signaturesofthepersonsperforminganddirectly
supervisingorcheckingeachcriticalstepinthe
operation.
In-processandlaboratorytestresults.
Actualyieldatappropriatephasesortimes.
Anydeviationnoted,itsevaluation,andinvestigation
conducted(ifappropriate)orreferencetothat
investigation(ifstoredseparately).

17. Resultsofreleasetesting.
Productionandqualitycontrolrecordsshouldbe
reviewedaspartoftheapprovalprocessofbatch
release.
Anydivergenceorfailureofabatchtomeetits
specificationsshouldbethoroughlyinvestigated.

18. BATCH MANUFACTURING ATTACHMENTS
Responsibility:-
Primary:-Production Chemist
Secondary:-Production Officer

19. FOLLOWING ATTACHMENTS REQUIRED TO BE
ATTACHED TO BMR BE COMPLETED BMR TO
QUALITY ASSURANCE: -
✓Equipment clean record status label.
✓Equipment clean record.
✓Raw materials dispensed weighing slip.
✓Intermediate raw material sealed.
✓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.

20. •MFR (Master Formula Record ).
•It should be available for each product, batch and pack
size.
•Master Formula Record (MFR) is a master document
for any pharmaceutical product.
•MFR contains all information about the manufacturing
process for the product.
•MFR is prepared by the research and development
team of the company.
•MFR is used as reference standard for preparing batch
manufacturing record (BMR) by manufacturing units.

21. •MFR is also called Master Manufacturing Record.
•MFR plays an important in consistency for each batch
manufacturing.

22. Content of MFR
Name, logo and address of the manufacturing
company.
Dosage form name.
Brand name.
Generic name.
Product code.
Label claim of all ingredients.
Product description.
Batch size.
Pack size and packing style.
Shelf life.
Storage conditions.

23. MFR number and date.
Supersede MFR number and date Effective batch
number.
Authorization by the production and quality assurance
head.

24. MFR Packaging details:-
There have to be authorized packaging instructions:
Name.
Description of dosage form.
Pack sizes-Number, dose volume.
AtotallistofallPackagingmaterialsrequiredfor
standardbatchsizewithreferencetothe
specificationsofthepackagingmaterial
Specimens of all packaging material.
Line clearance instructions.
Description of packaging operations.
In process controls.