All INFORMSTION ABOUT MASTER FORMULA GENERATION

1. DEPRTMENT OF PHARMACEUTICAL SCIENCES
Dr. HARI SINGH GOUR VISHWAVIDYALAYA
SAGAR (M.P.) 470003
(A CENTRAL UNIVERSITY)
SUBMITTED BY:
SURUCHI DAHIYA
(Y22254028)
M. PHARM ; SEM 2
SUBMITTED TO :
DR. DHARMENDRA JAIN
ASSISTANT PROFESSOR , DOPS
MR. SUNNY RATHEE
RESEARCH SCHOLAR
MASTER FORMULA GENERATION AND MAINTENANCE
SUB- DRA,IPR,AND QC
( MID 2 ASSIGNMENT)

2. CONTENTS -
1. Introduction
2. Need of master formula
3. components of master formula
4. Steps to prepare MFR
5. Challenges in maintenance
6. Important of maintenance
7. Master formula maintenance process
8. References

3. 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. MFR is also called Master Manufacturing Record, Master
Production Record.

4. MASTER FORMULA
RECORD
FACILITATION
OF SCALE UP
EFFICIENT
TRAINING
REDUCTION IN
ERROR
CONSISTENCY
IN PRODUCT
QUALITY REGULATORY
COMPLIENCE
ADAPTABILIT
Y TO
CHANGES
CONTINOUS
IMPROVE
NEED OF MFR

5. COMPONENTS OF MFR
The components of a master formula
1.Product Information
2.Ingredients and Materials
3.Measurements and Quantities
4.Processing Steps
5.Instructions and Procedures

6. 6.Packaging and Labeling
7.Quality Control and Testing
8.Environmental and Safety Considerations
9.Change Control and Version History
10.References and Attachments
11.Approval and Signatures

8. STEPS TO PREPARE MFR
• MASTER FORMULA RECORD: Production Department in association with
R&D, shall prepare MFR.
• MFR shall prepared as per the format attached with this SOP.
• MFR shall be divided into two parts:
1. Packaging part
2. Manufacturing part

9. FIRST PAGE
• 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 : this should include all ingredients and text included in product
permission

10. 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• Superseded Master card number and Date.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 Master Formula Record by all the responsible
members

11. THE SECONDARY PAGES
• 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

13. MASTER FORMULA GENERATING BY
• the Master Formula Record:
• responsible departments:
• Primary Responsibility: R&D and Production Department
• Secondary Responsibility: Quality Assurance Department
• accountability: head-quality assurance shall be responsible for implementation of
sop.

14. MASTER FORMULA MAINTENANCE PROCESS
1. Established of maintenance schedule
2. Cross-Functional Team Formation
3. Identify Triggers for Updates
4. Document Proposed Changes
5. Review and Approval
6. Update the Master Formula
7. Quality Control Check

15. • 8. Training and Communication:
• 9. Implementation:
• 10. Record Keeping.
• 11. Continuous Monitoring:
• 12. Regulatory Compliance.
• 13. Feedback and Improvement:.
• 14. Utilize Technology.
• 15. Periodic Audits

16. CHALLENGES IN
MAINTENANCE OF MASTER
FORMULA
EQUIPMENT UPGRADES OR CHANGES
DOCUMENTAION MANAGEMENT
PROCESS IMPROVEMENT
DATA ACCURACY
REGULATORY CHANGES
TRAINING AND COMMUNICATION

17. REFERENCES
1. Pharmaceutical process validation : An overview , by Md Shoaib Journal of
advanced pharmacy education & research ,oct-dec 2012,vol 2, issue 4, page no:
190-196 24
2. Jochen R, Landgraf K. Quality management benchmarking: FDA compliance in
the pharmaceutical industry. International journal of health care quality
assurance. 2010 oct 5;23(8):690-8.
3. Mishra A, Sharma N, Iyer R. International journal of pharmaceutical research
and bio-science.
4. A Textbook of Pharmaceutical quality assurance by Mr. Sanjay A. Namdev, Mr.
Mayur R. Bharat, Dr Md. Rageb Md. Usman Dr Krishna R. Gupta, Dr Upendra
B.