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Master Formula Master Formula And Batch And Batch
MaNUFACTURING MaNUFACTURING RecordRecord
Introduction:
MFR: Definition:
“An approved master document that describes the full process of manufacturing for the batch of specific product.”
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Definition:
According to various guidelines,
WHO
EU
Health Canada
US
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Different Names Of MFR:
MFR (INDIA)
MFPI(TGA , AUSTRALIA)
MMI AND MPI (MCC IN SA)
MFPI (WHO)
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A MFR is required for each batch and batchsize.
Definition of Batch:
It is single process or series of process.
Definition of Lot:
It is the final product in the final container.
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Instructions for the preparation of Instructions for the preparation of MFRMFR : :
Purpose
Objective
Scope
Responsibility
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Procedure :
Master document include following:
The name and reference code.
The proprietary name, generic name, strength ,
batch size of the product.
The expected final yield.
Processing instructions.
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Instructions for In-process controls.
Storage conditions.
Packing detail.
Abbreviations.
Copies to Distribution Sites.
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Content of MPF (WHO):Name with reference code.
Description.
List of starting material.
Final yield.
Location.
Process instruction.
Storage.
Precaution.9
Contents of MPF (WHO):Contents of MPF (WHO): Name of the product.
Description.
Pack size.
Complete list of packaging material.
Relevant printed packaging materials &
Specimens.
Special precautions.
Description of the packaging operation.
Details of in-process controls with instructions. 10
Batch Processing & Control Record:Batch Processing & Control Record: Definition :
B.P.C.R. is primarily a replica of the M.P.C.R.,
additionally it gives the actual process record of the batch
produced and help in maintaining the complete production
and control history of the batch.
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Different Names of BPCR: BMR (INDIA)
BP and BPR (WHO)
BMR and BPR (MCC, SA)
BP and BPR (MHRA)
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BPCR are required to be maintained for each batch of product
manufactured.
These should be based on MFR.
Method of preparation of BPCR should be such that transcription
errors do not occur.
Before any process begins a check should be made to ensure that
all work stations are clear of previous product, material and
documents. This check should be recorded.
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Essential Components of a Batch Record:
Document Identification.
Company Name.
Dates of Manufacturing.
Product Identification.
A step by step account of the processing and
testing to be done.14
The monitoring specifications-how will the
operators know if the process is proceeding
properly.
Raw data must be collected and blanks must be
filled in with the information.
Materials and equipment used .
Signatures required.
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Batch Processing Records:
A batch processing record should be kept for each
batch processed.
It should be based on the relevant parts.
Before any processing begins, a check should be
made.
This check should be recorded.
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Content of BPR:Name , number of the batch being manufactured.
Dates and times.
Name of the person responsible.
Batch / lot number and the quantity of each
starting material actually weighed.
Relevant processing operation.
Amount of product obtained.
Notes on special problems.17
Batch Packaging Records:
A batch packaging record should be kept for each
batch or part batch processed.
Based on the relevant parts of the approved
packaging instructions.
Before any packaging operation begins, checks should
be made.
These checks should be recorded.18
Content of BPR: Name , batch number, quantity of bulk product.
Date and Time.
The name of the responsible person.
Identity.
Details of the packaging operations.
Batch number, expiry date, and any additional
overprinting
Special problems. 19
Basic Difference: B/W MPCR and Basic Difference: B/W MPCR and BPCR:-BPCR:-MPCR is the type of master document, means with
the help of MPCR only, the BPCR is prepared.
BPCR is unique batch wise, means all batches have
their individual BPCR.
Moreover BPCR contains ‘Date and Time’, that when
the batch was processed.
MPCR is the reference copy.20
Example of BMR:Name of product: Alerid Tablet Batch no.: Batch size:Date of Mfg commencement:Date of Mfg Completed:
Temperature: 0CHumidity: % Page No. 21
Sr. No.
Ingredient A.R. No. Quantity(Kg)
Weighed by
Checked by
Prepared Date & Timeby
Stage: Shifting or sievingName of product:Batch no.:
Date: Started on: Completed on:
Time:Temp.: 0C. Humidity: %.
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Sr. No.
Ingredient Equip-ment No.
Equip-ment cleaned by
Equip-ment checked by
Sieve no. #
Previous Product
Operat-or
Sign Of superv-iser
Stage: MixingName of product:Batch no.:
Time of mixing: Mins.Temperature: 0CHumidity: %
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Sr. No.
Ingredient AddedBy
Checkedby
Equip-ment No.
Equip-ment cleaned by
Equip-ment checked by
Previous Product
DateAndtime
Stage : DryingStage : Drying
Name of product:Batch no.:
Temperature: 0C Date & Time :Humidity: %
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Equip-ment No.
Previous Product
Inlet Temp.(0C)
Outlet Temp.(0C)
TimeOfDrying
IPQCL.O.D.
Operator CheckedBy
Stage: Milling Stage: Milling Name of product:Batch no.:
Practical Yield: %.Temperature: 0CHumidity: %.
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Equip-ment No.
Previous Product
MeshSize
Operator CheckedBy
DateAndTime
Stage: LubricationStage: LubricationName of product:Batch no.:
Temperature: 0CHumidity: %.
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Equip-ment No.
Previous Product
TimeOfBlending
Lubrica-ntAdded
LubricantAddedBy
CheckedBy
VerifyBy
DateAndTime
Stage: CompressionStage: Compression
Name of product:Batch no.:
Temperature: 0CHumidity: %.
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Equip-ment No.
Equip-ment cleaned by
Equip-ment checked by
Previous Product
SpeedOfMachine
WeighedBy
CheckedBy
DateAndTime
Stage: CoatingStage: CoatingName of product:Batch no.:
Temperature: 0CHumidity: %.
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Sr.No
Ingredient Equip-ment No.
Previous Product
Quantity A.RNo.
WeighedBy
CheckedBy
DateAndTime
Stage: Packaging
Name of product:Batch no.:
Temperature: 0CHumidity: %.
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DateOfPackaging
Equip-ment No.
Equip-ment cleaned by
Equipment checked by
LineClearance
CheckedBy
DateAndTime
Stage: StorageStage: Storage
Name of product:
Batch no.:
Date of completion:
Mfg date:
Exp date:
Temperature: 0C
Humidity: %.30
MF and corresponding Batch Records: MF give the complete production instructions.
Blank spaces are provided for the entry of data.
The BPR is the approved copy of the master document with
filled in data entries.
Once a final product has been produced, BR is comprised
of a single document.
The product is a pool of several intermediates or final bulks
then the full batch record includes the individual batch
records of all the components.31
Issuing of MF copy as a blank BR:
MF are almost invariably stored on the computer.
QA is responsible to generate a copy.
The MF should make reference to in process tests, QC
tests.
The batch record, however, includes the record sheets
of all the production records and support records.32
Master formulae, once approved and signed, should remain under the control of QA.
Master copies of the MF can be distributed to
relevant departments if needed.
There will obviously be company-by-company differences in the details of the procedures for QA approval and issuing of MF.
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Electronic MF and BR: The MF is invariably on the computer, and should be under
pass-word control of QA.
Photocopies – stamped, numbered, and on a distribution list -
may be issued as reference copies to the relevant department
head.
The electronic version may have the signature and date fields
typed in, e.g. "official copy signed by XXX”; “official copy
dated ddmmyy”.
If the electronic copy is printed out as the BBR for each
production run, the QA department must stamp each page of the
printout and sign that it is the approved current MF. 34
References :-References :-www.who.in
www.law.justia.com
www.ncbi.com
www.law.cornell.edu
www.cgmp.com
www.qualityassurancepharma.blogspot.com
Prof. Manohar A.Potdar,“Pharmaceutical Quality
Assurance,”by Nirali Prakashan Page no.7.7-7.1435
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