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 – Ranjit Thavare
T Y B Pharmacy, Div. A
Yahwantrao Bhonsale college of Pharmacy

2. 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.
▪ MFR is used as reference standard for preparing batch
manufacturing record (BMR) by manufacturing units.

3. ▪ MFR is also called Master Manufacturing Record, Master
Production Record.
▪ There shall be Master Formula records 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.
▪ MFR plays an important in consistency for each batch
manufacturing

4. DEFINATION
“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-processcontrols.”

5. ❖ Master formula records for each product should be
prepared, endorsed, and dated by a competent and
responsible individual and should be independently
checked, endorsed, and dated by another competent and
responsible individual.
❖ The information contained in the records should be
provided in a format and language that will not be
misinterpreted by the operating personnel and the
supervisor, to ensure that each batch of a product can be
identically reproduced.

6. MFR should include -
MFR includes all manufacturing proceduresfor each batch product and
batch size to be manufactured and these shouldbe signed by head of
productionand qualitycontroldepartment. The master formula should
include:
1. Name,Product code & address of the manufacturing company :-The
name of the product togetherwith productreference code relatingto
its specification.
2. Dosage formname, Brand name &Generic name :- The patent or
proprietaryname of the productalong with the genericname,
descriptionof dosageform, strength, composition and batch size

7. 3. Product code & Label claimof all ingredients :-Name and reference
numbers of all startingmaterials used.
4. Manufacturing Process:- Methodsof cleaning, assembling, calibration
and sterilizationof equipment. Stepwiseprocessinginstructionsand time
taken for each step.
5. Instruction for IPQC with their limits. Storageconditionsof the
productand detailsabout 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. Flow Chart: Steps of the manufacturing process to be monitored. Flowchart
of the material movement from dispensing to the final product to stores.
13. Equipment: Create a list of all required equipment and machines required in
the manufacturing process with their capacity.
14. Special instructions: Write down the precautions special instructions to follow
during the product manufacturing and packing and these should also be added in the
batch manufacturing formula.
15. 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.

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 !