Master formula record.pdf

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.

1. MASTER FORMULA
RECORD
Presented by –
17 –Mitesh Janvalkar
35 –Trupti Morajkar
51 –MohiniTawade
52 –RanjitThavare
T Y B Pharmacy, Div. A
Yahwantrao Bhonsale college of Pharmacy

2. INTRODUCTION
▪MasterFormulaRecord(MFR)isamasterdocumentforany
pharmaceuticalproduct.
▪MFRcontainsallinformationaboutthemanufacturingprocess
fortheproduct.
▪MFRispreparedbytheresearchanddevelopmentteamofthe
company.
▪MFRisusedasreferencestandardforpreparingbatch
manufacturingrecord(BMR)bymanufacturingunits.

3. ▪MFRisalsocalledMasterManufacturingRecord,Master
ProductionRecord.
▪ThereshallbeMasterFormularecordsrelatingtoall
manufacturingproceduresforeachproductandbatchsizetobe
manufactured.Theseshallbepreparedandendorsedbythe
competenttechnicalstaffi.e.headofproductionandquality
control.
▪MFRplaysanimportantinconsistencyforeachbatch
manufacturing

4. DEFINATION
“Adocumentorsetofdocumentsspecifyingthestarting
materialswiththeirquantitiesandthepackaging
materials,togetherwithadescriptionoftheprocedures
andprecautionsrequiredtoproduceaspecifiedquantity
ofafinishedproductaswellastheprocessing
instructions,includingthein-processcontrols.”

5. ❖Masterformularecordsforeachproductshouldbe
prepared,endorsed,anddatedbyacompetentand
responsibleindividualandshouldbeindependently
checked,endorsed,anddatedbyanothercompetentand
responsibleindividual.
❖Theinformationcontainedintherecordsshouldbe
providedinaformatandlanguagethatwillnotbe
misinterpretedbytheoperatingpersonnelandthe
supervisor,toensurethateachbatchofaproductcanbe
identicallyreproduced.

6. MFR should include -
MFR includes all manufacturing procedures for each batch product and
batch size to be manufactured and these should be signed by head of
production and quality control department. The master formula should
include:
1.Name,Productcode & address of the manufacturing company :-The
name of the product together with product reference code relating to
its specification.
2.Dosage form name, Brand name &Generic name :-The patent or
proprietary name of the product along with the generic name,
description of dosage form, strength, composition and batch size

7. 3. Product code & Label claim of all ingredients :-Name and reference
numbers of all starting materials used.
4. Manufacturing Process:-Methods of cleaning, assembling, calibration
and sterilization of equipment. Stepwise processing instructions and time
taken for each step.
5. Instruction for IPQC with their limits. Storage conditions of the
product and details about the containers, labels and packing.

8. 8
6. Batch size
7.Pack size and packing style
8.Shelf life
9.Storage conditions
10.MFR number and date
11.Authorization by the production and quality assurance
head

9. 12.FlowChart:Stepsofthemanufacturingprocesstobemonitored.Flowchart
ofthematerialmovementfromdispensingtothefinalproducttostores.
13.Equipment:Createalistofallrequiredequipmentandmachinesrequiredin
themanufacturingprocesswiththeircapacity.
14.Specialinstructions:Writedowntheprecautionsspecialinstructionstofollow
duringtheproductmanufacturingandpackingandtheseshouldalsobeaddedinthe
batchmanufacturingformula.
15.Calculations:Includethecalculationstepsofallactivematerialstogetthe
100%oftheactivematerial.ThecalculationshallbedoneusingwaterorLODto
get100%potency.

10. 16. Manufacturing Process: Write all steps in all stages of the
manufacturing process. All process steps like shifting, milling, lubricating,
granulation, compression and coating should be written in detail including
the process time and yield. It also include atmospheric conditions as
temperature, humidity, and storage conditions for every step.
17. Packing Process: List of all packing materials with their quantity is
written. Line clearance, reconciliation of printed and unprinted packing
materials should be included in details.
18. Yield: Include the theoretical, actual yield and acceptance limit of the
batch.

11. Master
Formula
Record

12. 12

13. Thank You !