Master Formula and Batch Manufacturing Record

A SEMINAR ON
Master Formula And

Batch
MaNUFACTURING
Record
1
Introduction:
 MFR:
 Definition:
“An approved master document that
describes the full process of
manufacturing for the batch of specific
product.”
2
Definition:
According to various guidelines,
WHO
EU
Health Canada
US
3
Different Names Of MFR:
MFR (INDIA)
MFPI(TGA , AUSTRALIA)
MMI AND MPI (MCC IN SA)
MFPI (WHO)
4
A MFR is required for each batch and batch
size.
 Definition of Batch:
It is single process or series of process.
 Definition of Lot:
It is the final product in the final container.
5
Instructions for the preparation of
MFR :
 Purpose
 Objective
Scope
 Responsibility
6
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.
7
Instructions for In-process controls.
 Storage conditions.
Packing detail.
Abbreviations.
Copies to Distribution Sites.
8
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):
 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:
 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.
11
Different Names of BPCR:
 BMR (INDIA)
 BP and BPR (WHO)
 BMR and BPR (MCC, SA)
 BP and BPR (MHRA)
12
 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.
13
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.
15
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.
16
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
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:
Sr. Ingredient A.R. No. Quantity Weighed Checked Prepared Date & Time
No. (Kg) by by by
Temperature: C
0
Humidity: % Page No. 21

Stage: Shifting or sieving
Name of product:
Batch no.:
Sr. Ingredient Equip- Equip- Equip- Sieve Previous Operat- Sign Of
No. ment ment ment no. # Product or superv-
No. cleaned checked iser
by by
Date: Started on:

Completed on:
Time:
Temp.: 0C. Humidity: %.
22
Stage: Mixing
Name of product:
Batch no.:
Sr. Ingredient Added Checked Equip- Equip- Equip- Previous Date
No. By by ment ment ment Product And
No. cleaned checked time
by by
Time of mixing: Mins.

Temperature: 0C
Humidity: %
23
Stage : Drying
Name of product:
Batch no.:
Equip- Previous Inlet Outlet Time IPQC Operator Checked

ment Product Temp.(0C) Temp. Of L.O.D. By
No. (0C) Drying
Temperature: C0 Date & Time :

Humidity: %
24
Stage: Milling
Name of product:
Batch no.:
Equip- Previous Mesh Operator Checked Date

ment No. Product Size By And
Time
Practical Yield: %.
Temperature: 0C
Humidity: %.
25
Stage: Lubrication
Name of product:
Batch no.:
Equip- Previous Time Lubrica- Lubricant Checked Verify Date
ment Product Of nt Added By By And
No. Blending Added By Time
Temperature: C0
Humidity: %.
26
Stage: Compression
Name of product:
Batch no.:
Equip- Equip- Equip- Previous Speed Weighed Checked Date
ment ment ment Product Of By By And
No. cleaned checked Machine Time
by by
Temperature: C
0
Humidity: %.
27
Stage: Coating
Name of product:
Batch no.:
Sr. Ingredient Equip- Previous Quantity A.R Weighed Checked Date
No ment Product No. By By And
No. Time
Temperature: C
0
Humidity: %.
28
Stage: Packaging
Name of product:
Batch no.:
Date Equip- Equip- Equipment Line Checked Date

Of ment ment checked by Clearance By And
Packaging No. cleaned by Time
Temperature: C
0
Humidity: %.
29
Stage: Storage
 Name of product:
 Batch no.:
 Date of completion:
 Mfg date:
 Exp date:
 Temperature: 0 C
 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
 Masterformulae, once approved and signed,
should remain under the control of QA.
 Mastercopies 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.
33
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 :-
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.7.7-7.14 35
36

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A SEMINAR ON

Master Formula And

Copies to Distribution Sites.

 List of starting material.

B.P.C.R. is primarily a replica of the M.P.C.R.,

 Method of preparation of BPCR should be such that transcription

 Before any process begins a check should be made to ensure that

A batch packaging record should be kept for each

Humidity: % Page No. 21

Date: Started on:

Time of mixing: Mins.

Equip- Previous Inlet Outlet Time IPQC Operator Checked

Temperature: C0 Date & Time :

Equip- Previous Mesh Operator Checked Date

Date Equip- Equip- Equipment Line Checked Date

 MF are almost invariably stored on the computer.

 Mastercopies of the MF can be distributed to

 There will obviously be company-by-company

 Prof. Manohar A.Potdar,“Pharmaceutical Quality

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