Regulatory affairs is a profession that developed to ensure public health by regulating product safety. Regulatory affairs professionals work with regulatory agencies and internal departments to register products, track legislation changes, and provide strategic advice. They must understand both internal manufacturing processes and requirements from agencies like CDSCO in India or the USFDA. A Master Formula Record (MFR) is a key document that contains all information about manufacturing a pharmaceutical product, including starting materials, packaging, and processing instructions. It is prepared by R&D as the standard reference for making Batch Manufacturing Records. The MFR must include product details, a procedure description, and all ingredients and their quantities. It ensures consistent manufacturing of batches according to the standard process.

1. REGULATORY AFFAIRS & Master
Formula Record
SACHIN SURYAWANSHI
M. PHARM

2. Regulatory affairs
 a comparatively new profession which
developed from the desire of governments
to protect public health by controlling the
safety and efficacy of products in areas
including pharmaceuticals, veterinary
medicines, medical devices, pesticides,
agrochemicals, cosmetics and
complementary medicines.
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3. Role of Regulatory Affairs
 Ragistration Documents To Regulatory
Agency
 To Keep Track On Every Change In
Legislation
 To Give Strategic And Technical Advice to
R&D Production And QC Department
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4. Departments In DRA
Drug Regulatory
Authorities
 CDSCO – India
 USFDA – US
 MHRA – UK
 TGA – Australia
 EMEA – Europian country
 MCC – South Africa
Internal Department Of
Organization
 Product Development
 Clinical Trail & Reserch
 Licencing
 QA
 QC
 Mfg
 Marketing
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5. MASTER FORMULA
RECORD
 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.
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6. Definition 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.”
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7. MFR 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
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8. Procedure to prepare a Master
Formula Record:
 A Master Formula Record is either prepared based
upon experience of competent qualified staff like
manufacturing chemist or analytical chemist or
prepared based upon batch manufacturing record
of a batch size.
 We can’t ignore Master formula record at any
level. Once Master Formula Record is prepared, it
is transferred to previous staff to new staff. It is
followed as standard documents for processing a
batch. Master Formula record is consider as
standard for making a Batch Manufacturing
Record.
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