Master Formula Record & its Importance B.Pharmacy 7th Semester 2025 (2024-2025) Previous Year's Question Papers/Notes Download - HK Technical PGIMS

Master Formula Record & its Importance

 CONTINUOUS ASSESSMENT 1

 Academic Year : 2024 - 2025
COLLEGE: CALCUTTA INSTITUTE OF PHARMACEUTICAL TECHNOLOGY & A.H.S.
Presented by- Farhan Aziz
Vision
➤ To be a premier institute and to achieve excellence in pharmacy education and research
Mission
➤ To create state-of-the art infrastructural facilities to enhance teaching-learning and research to achieve excellence
➤ To promote innovation in teaching-learning by organizing faculty development programmes for continuous improvement in
education system to meet the needs of health-care and pharmaceutical industry
➤ To develop closer interface with pharmaceutical industry and research institutes to promote collaborative research to
ultimately become a resource centre
Programme Educational Objectives
PEO 1:- To prepare Pharmacy graduates capable of applying principles and technologies for formulation,
Development and manufacture of drugs and pharmaceuticals
PEO 2:- To produce pharmacists to serve society as the profession responsible for appropriate use of medication
and device to achieve optimal therapeutic outcomes
PEO 3:- To promote leadership and entrepreneurship qualities, human values and professional ethics.
PEO 4:- To organize workshops for hands-on-training and skill development
PEO 5:- To promote awareness on clean and green environment
Name Slide No
1. Introduction :
2. MFR Should Include :
3. SOP for Preparation of MFR :
4. Steps to Prepare MFR :
5. Formats of MFR :
6. Conclusion :
7. Reference :
10
❖ Contents :
➢ A Master formula record is a document or set of document specifying the starting material
 With their quantities and packaging material together with a description of the procedure
 Which is required to produce a specific quantity of finished product as well as processing
 Instruction, including the process control.
➢ MFR content all information about the manufacturing
 Process of product.
➢ It is prepared by the research & development team of
 A company.
➢ MFR can be use as reference standard to prepare
 Batch Manufacturing Records.
➢ Also called as Master Manufacturing Record or
 Master Production Record.
❖ Introduction :
Mater formula Records
❖ MFR Should Include :
➢ A master formula record should be content various things include :
1.Product Details:
➢ Name, logo & Address of the manufacturing company.
➢ Dosage form name
➢ Brand Name
➢ Generic Name
➢ Product Code
➢ Label claim of All Ingredients
➢ Product Description
➢ Batch Size
➢ Packaging Size & Style
Logo of Product
Product Code
1.Product Details:
❖ MFR Should Include :
➢ Shelf life of product.
➢ Appropriate storage condition.
➢ MFR no & date.
➢ Effective batch number.
➢ Authorization by production & Quality Assurance Department.
2. Equipment: list of Required Equipment and machines used for manufacturing process
 Should be include.
3. Flow Chart: All steps of manufacturing process should be written.
4. Calculation: Calculation steps of individual material should be written.
5. Special Instruction: Write down all precautions for handling of API.
❖ MFR Should Include :
6.Manufacturing Process: All steps of manufacturing process like Size reduction, Granulation,
 Compression & coating should be written including process time
 & yield.
7.Product Details: The amount of Theoretical & practical yield of each batch included.

Size Reduction by Hammer Mill Tablet Compression Machine
❖ SOP for Preparation of MFR:
Responsible
department
Quality
Assurance
Department
Primary
Responsible
Department
Secondary
Responsible
Department
F&D and
Production
Department
❖ Steps to Prepare a MFR :
➢ A Master Formula Record shall be prepared according to SOP.
➢ MFR divided into 2 sections ;
MFR
Manufacturing
 part
Packaging
 part
➢ Manufacturing Part:
➢ The first page of both sections shall containing details : Name, Address , Dosage form
 Brand & Generic name, Product code, label containing all ingredients, shelf life &
 Storage condition.
➢ The second page should contain manufacturing process steps, list of equipment, machines
➢ Subsequent page should include precaution taken during manufacturing.
➢ The packaging section of master formula record should include complete list of all the
 Packaging materials, their size, types etc,
➢ Any special precaution taken during packaging should include in Master Formula Record.
❖ Steps to Prepare a MFR :
➢ Packaging Part:
Secondary packaging Packaging in vials
❖ Formats of MFR :
Page 1 page 2
❖ Conclusion :
➢ Mater Formula Record plays important role in documentation to maintain consistency of
 each batch.
➢ It specifies starting materials, quantities , packaging material and processing instruction
 for producing specific quantity of finished product.
1. Dr. Swarnali Das Paul, Mrs. Gunjan Jeswani. ' Master Formula Records'. Pharmaceutical
 Quality Assurance. Pee Vee, Panjab(1); 2020; 196-199
2. Gaurav Agarwal, Jyoti Ghangas. 'Preparation of Master Manufacturing Procedure'. Industrial
 Pharmacy II. CBS Publisher & Distributors Pvt Ltd; New Delhi(1);2020;12-13.
3. Anusuya R. Kashi, Bindu Sukumaran, Veena P. et al. 'Master Formula Record'. Pharmaceutical
 Quality Assurance. Nirali Prakashan; Pune(1);2020;13.5-13.6.
4. Graham P. Bunn. 'Master Production & Control Records'. Good Manufacturing Practice for
 Pharmaceuticals. CRC Press, London(7);2019;106-109.
❖ Reference :