Master Formula Record
(MFR)
Dr. Jitendra
Gupta
Asst. Prof.
Institute of Pharmaceutical Research
GLA University, Mathura
2020-21
MASTER FORMULA RECORD (MFR)
MASTERFORMULA
MASTER FORMULA RECORD
RECORD (MFR)
(MFR)
MASTER FORMULARECORD
MASTER FORMULA RECORD (MFR)
(MFR)
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.
MFR is also called Master Manufacturing Record (MMR), Master
Production Record (MPR).
Definition
Definition(MFR)
(MFR)
“A document or set of documents specifying the starting materials with
their quantities and the packaging materials, together with a description of
the procedures and precautions required to produce a specified quantity of
a finished product as well as the processing instructions, including the in-
process controls.”
• Document or set of documents.
• Starting materials with their quantities .
• Packaging materials.
• Description of the procedures and precautions .
• Finished product as well as the processing instructions.
There shall be MFR relating to all manufacturing procedures for each
product and batch size to be manufactured.
These shall be prepared and endorsed by the competent technical staff i.e.
head of production and quality control (Head of Production and Q.C.).
MFR plays an important in consistency for each batch manufacturing.
MASTER
MASTER FORMULA RECORD(MFR)
FORMULA RECORD (MFR)
It should include product details :
• 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
• MFR number and date
• Supersede MFR number and date
• Effective batch number
• Authorization by the production and quality assurance head
FlowChart:
Flow Chart
• Steps of the manufacturing process to be monitored.
• Flow chart of the material movement from dispensing to the final
product to stores.
Equipment
Equipment:
• Create a list of all required equipment and machines required in the
manufacturing process with their capacity.
Specific
Special Instructions
instructions:
• Write down the precautions special instructions to follow during the
product manufacturing and packing.
• These should also be added in the batch manufacturing formula (BMR).
Calculation
Calculations:
• Include the calculation steps of all active materials to get the 100% of the
active material.
• The calculation shall be done using water or LOD to get 100% potency.
Manufacturing
Manufacturing Process
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.
Packaging process
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.
Yield
Yield:
• Include the theoretical, actual yield and acceptance limit of the batch.
Procedure to prepare a Master Formula
Record (MFR):
• A MFR is prepared either based upon experience of
competent qualified staff like manufacturing
chemist or analytical chemist or prepared based
upon batch manufacturing record (BMR) of a
batch size.
We can’t ignore MFR at any level.
Once MFR is prepared, it must be transferred to previous staff to new
staff.
It is followed as standard documents for processing a batch.
MFR is consider as standard for making a Batch Manufacturing
Record (BMR).
SOP for preparation of the MFR
RESPONSIBLE DEPARTMENTS:
• Primary Responsibility:
F & D and Production Department
• Secondary Responsibility:
Quality Assurance (Q.A.) Department
ACCOUNTABILITY:
Head-Quality Assurance shall be responsible for implementation of SOP.
STEPS TO PREPARE A MFR:
Production department in association with F&D, shall prepare MFR.
MFR shall prepared as per the format attached with this SOP.
MFR shall be divided into two parts:
Manufacturing part
Packaging part
The first page of both the sections shall have following details:
Name, address and logo of the company
Dosage form
Brand name
Generic name
Product code
Label claim : It include all ingredients and text included in product permission.
Product Description
Batch Size, Pack Size
Shelf Life
Storage conditions
Drug Schedule: whether schedule H or schedule G drug.
Superseded Master card number and Date.
Present Master card number and Date.
Present Master card effective Batch number.
Reference of changed control number.
There shall be authorization of MFR by all the responsible
members.
The secondary page of manufacturing section shall include-Process
steps to be monitored.
Subsequent pages shall include the processes to be monitored. The
stage wise movement of material in a form of flow chart.
The list of equipment, machines, utensils to be used, shall be described.
The subsequent page shall include any special precautions to be taken
for the product during manufacturing and packing.
The same page should also include Batch Manufacturing Formula
(BMF).
Batch Manufacturing Formula (BMF) should have the
following columns:
Serial number
Name of ingredients
Reference of specifications of ingredients
Quantity to be added (in mg/ml or per tablet or per
capsule or per g as the case may be)
Overages to be added (in %)
Below that give the calculation step for every active material,
ensuring that the active material shall be compensated for assay
values less than 100% which could be due to less potency or higher
moisture content.
At the end of every important stage, include a statement of the
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 methods or the reference of the methods/procedures to employed for
preparing, cleaning, assembling, operating the various equipments shall be given.
Include detailed stepwise processing instructions.
Example: Checks on materials, pretreatments, sequence for adding materials,
mixing times, temperatures, humidity etc.)
Includes the requirements for storage conditions of the products.
• The packaging part of MFR should include complete list of all the packaging materials
required for a standard batch size, including quantities, sizes and types.
• Include line clearance checking during batch coding & batch packaging operations.
• Includes reconciliation of printed & unprinted packaging materials with acceptable limits.
• Includes destruction of excess or rejected printed packaging materials
• Includes description of packaging operation including any significant subsidiary
operations and equipment to be used.
MASTER FORMULA RECORD (MFR)
MASTERFORMULA
MASTER FORMULA RECORD
RECORD (MFR)
(MFR)
RECOMMENDED BOOKS
1. Generic Drug Product Development, Solid Oral Dosage forms, Leon Shargel and
IsaderKaufer,Marcel Dekker series, Vol.143.
2. The Pharmaceutical Regulatory Process, Second Edition Edited by Ira R. Berry and
Robert P.Martin, Drugs and the Pharmaceutical Sciences,Vol.185, Informa Health
care Publishers.
3. New Drug Approval Process: Accelerating Global Registrations By Richard A
Guarino, MD,5th edition, Drugs and the Pharmaceutical Sciences,Vol.190.
4. Guidebook for drug regulatory submissions / Sandy Weinberg. By John Wiley &
Sons.Inc.
5. FDA regulatory affairs: a guide for prescription drugs, medical devices, and
biologics/edited By Douglas J. Pisano, David Mantus.
6. Clinical Trials and Human Research: A Practical Guide to Regulatory Compliance
By Fay A.Rozovsky and Rodney K. Adams
7. www.ich.org/
THANK YOU
