MASTER FORMULA

RECORD
Presented by: Aiyushi Das
M.Pharm ( Pharmaceutics department)
INTRODUCTION
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.
MFRis used as reference standard for preparing batch
manufacturing record
(BMR)by manufacturing units.
MFR is also called Master manufacturing record, master production
record.
DEFINITION
Master formula record or MFR is defined as “An approved master
document that describes the full process of manufacturing for the
batch of specific product.”
Master manufacturing document is prepared for a particular
product, describing, all technical details, required to do error less
manufacturing of a particular product, up on which all validation are
done.
According to WHO GMP Guidelines, a formally authorized master
formula should exist for each product and batch size to be
manufactured.
Importance of documentation
• It provides necessary working details.
• Reduce the risk of mistake.
• Help in tracing the deviation from the excepted yield.
• They help in decreasing the batch-to-batch variation so that
quality of product is kept within the limit of acceptability.
• Considered as the history of batch operation.
• Self –inspection of procedure.
• Documentation and records are essential for obtaining
accreditation, certification of ISOs and approvals by federal bodies.
Preparation of master formula record:
A MFR should have following parts:

1.It should include name, logo, Product description

and address of the Batch
manufacturing company size
Pack size and packing style
Dosage form name
Shelf life
Brand name
Storage condition
Generic name
MFR number and date
Product code
Label claim of all ingredients
2.FLOW: steps of the manufacturing process to be monitored. flowchart of
the materials movement from dispensing to the final product to stores.
3. EQUIPMENT: create a list of all required equipment and machines
required in the manufacturing process with their capacity.
4. Calculations: include the calculation steps of all active materials to get
the 100% of the active material. The calculations shall be done using
water content.
5. 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.
6. Manufacturing process: write all steps in all stages of the manufacturing
process. all process steps like shifting, milling, lubricating, granulations,
compression and coating should be written in detail including the process
time and yield it also includes atmospheric conditions as temperature
humidity, and storage condition for every step.
7. Yield: include the theoretical, actual yield and acceptance limit of the
batch.
Procedure to prepare a MFR:
• STEPS TO PREPARE A MASTER FORMULA RECORD:
Production department in association with F&D, shall prepare MFR.
MFR shall be prepared as per the format attached with SOP.

Packaging
Part

MFR
Manufacturi
ng Part
 • SOP FOR PREPARATION OF MFR

• Note: Accountability:- Head–Quality assurance shall be responsible for implementation of SOP.

• THE FIRST PAGE OF BOTH THE SECTIONS SHALL HAVE
COMPLETE PRODUCT DETAIL ALONG WITH :-
 Drug schedule: whether schedule H or schedule G drug.
Superseded master card number & date.
Present master card number & date.
Reference of changed control number.
The secondary page of manufacturing section shall include process
to be monitored.
Subsequent pages shall include the process to be monitored. The
stage wise movement of material in a form of flow chart.
The list of equipment, machines, apparatus to be used, shall be
described.
The subsequent page shall include any special precautions to be
taken for the product during manufacturing and packaging.
 The same page should also include batch manufacturing formula
BATCH FORMULA SHOULD HAVE THE FOLLOWING COLUMNS :-
Serial number
Name of ingredients
Reference of specification of ingredients
Quantity to be added
Overages to be added (in %)
Quantity to be added per batch or per lot
At the end of every important stage, include a statement of yield with
the acceptable limits.
Include in-process quality checks during and at the end of important
steps and stages with their limits.
The process shall include the process equipment to be used. The
method or the reference of the method/procedure to be employed for
preparing, cleaning, assembling, operating the various equipment
shall be given.
 INCLUDE THE REQUIREMENTS FOR STORAGE CONDITIONS OF THE
PRODUCT :-

The packaging part of MFR should include complete list of all the
packaging material required for a standard batch size, including
quantities, sizes and types.
Includeline clearance checking during batch coding and batch
packaging operations. 
Include reconciliation of printed and imprinted packaging materials
with acceptable limits.
Includes description of packaging operation including any significant
subsidiary operations and equipment to be used.
 ISSUING OF MF :

MF once signed once approved and signed should remain under the
control of QA Dept
When revision are made, a new version is assigned a new version
number, approval’s signature and effective dates added.
 MF copies are distributed to relevant department and in a production
run should be distributed along with stamp by the QA Dept
MASTER FORMULA RECORD PAGE 1 :
PAGE 2 :
PAGE 3 :
BATCH MANUFACTURING RECORD:
 LET CONSIDERED MFR OF EYE/EAR DROPS
Purpose: master formula record (MFR) is written to describe the
formulae, manufacturing, procedure, specifications, packing details
of dosage form.
Scope:This MFR is performed and is applied during the
manufacturing of dosage form.
Responsibility / accountability: it is the responsibility of
manufacturing chemist to follow and adhere to this MFR. The
production manager, QC/QA manager are accountable for the strict
adherence to the master formula
Copy issued to:
1. Master copy: manager quality assurance.
2. copy no 1: production manager
3. copy no 2: manager quality control
4. copy no 3. small volume Parenteral section.
• EQUIPMENT TO BE STERILIZED:

SR NO NAME OF STERILIZATION AS
EQUIPMENTS PER SOP NO
1 S.S MEMBRANE
FILTER ASSEMBLY
2 S.S FILLING VESSEL
3 S.S FILLING SYRINGES
4 STERILE DRESS OF
OPERATION
5 PRE NITOGENFILLING
AND POST NITOGEN
FILLING NEEDLES

6 SILICON TUBES
• RAW MATERIALS:
S.N INGREDIENTS STD QTY TAKEN
O
1 BORIC ACID I.P 0.200
2 BORAX I.P 0.320

3 BETAMETAHSSONE I.P 100

NA PO4
4 BEZYLKONIUM I.P 0.02
CHLORIDE
5 EDTA I.P 0.042

6 DI NA H I.P 0.280
ORTHOPHOSPHATE
7 NEOMYCIN SULHATE I.P 0.500

8 NA DI H I.P 0.066
ORTHOPHOSPAHTE
9 TWEEN -80 I.P 0.040
PACKING MATERIALS :

S.NO NAME OF THE MATERIALS

1 10ML PLASTIC VIALS WITH CAP & NOZZLES

(STERILIZED)
2 ADHESIVE TAPE ROLL BROWN

3 CELLO TAPE

4 CORRUGATED BOX

5 STICKER LABEL

6 UNIT CARTONS

7 OUTER CARTONS

8 INSERTS
MANUFACTURING PROCESS :
1. Preparation of solution
2. Take in SS batch mixing tank (IN-1A) 70 L of freshly prepared distilled water
3. Dissolve boric acid and borax in 10L of water and add to batch mixing tank
stir it properly.
4. Dissolve betamethasone sodium phosphate and stir properly.
5. Dissolve Di sodium orthophosphate and monosodium orthophosphate and
trisodium phosphate and add to the mixing tank stir it properly.
6. Dissolve SMBS & EDTA in water and pour in tank
7. Dissolve benzalkonium chloride and to the mixing tank
8. Dissolve neomycin sulphate and add to the mixing tank
9. Dissolve tweens – 80
10. Adjust the PH rang to 7.01 (PH range 6.08 to 7.2)
11. Make up the volume to 100 liters
12. Shift the solution from batch mixing tank to pressure vessel and do
membrane filtration.
Filtration: filtration is done with the membrane assembly by using the
appropriate pre filter and. post filter i.e. membrane

A PRE FILTER 1.5µ

B MEMBRANE FILTER 0.2µ

ASPECTIC FILLING: After the process of washing sterilization filtration filing

of aseptic filing is carried out in class 100 area under the laminar flow. The
machine adjusted is carried out for the appropriate vials.

FILLING STATION YES/NO YES

B BUTYL BUNG YES/NO NO
C SEALING STATION YES/NO YES

Volume variation is checked intermittently volume prescribed 5ml, and volume filled
5.05 ml, percentage variation 10%
• Labeling: labeling of vials is done with help of auto vials labeling
machine.
• Packing :
1 Open Yes/no yes Pack 24*24
packing size
2 Blistering Yes/no No Pack size NA
packing

• Packing details:
1. Pack the filled vials unit carton
2. Pack such 24 cartons in each outer carton
3. Seal outer carton with cello tape
4. Pack the 24 outer cartons in specified corrugated box to give Pack size
of 24*24 *10ml .
5. Seal the corrugated box with adhesive tape and label it properly by
affixing the specified label
• In process controls:
1. Check raw materials used for manufacturing purpose are all
approved materials and have ‘released labels fixed on it.
2. Physical characteristics of raw materials like color, odor, and
consistency are checked before compounding
3. Final volume should be made as per standard operating
procedure.
4. PH of the bulk should be sent for analysis to q.c department
before starting the filling and sealing stage.
5. The labels and cartons should be checked thoroughly for proper
batch coding.
6. Carry out bubble test for checking the integrity of membrane
filter as per SOP
THANK YOU