This document provides information on master formula records and drug master files. It was prepared by Kashish Wilson of MM College of Pharmacy. The document defines a master formula record as a document specifying starting materials, packaging materials, processing instructions, and in-process controls for a product. There shall be a master formula record for each product and batch size. It also describes drug master files as submissions to regulatory agencies that provide confidential manufacturing information and lists the five types of drug master files.

1. MFR
DMF
LOA
PREPARED BY
KASHISH WILSON
M M COLLEGE OF PHARMACY

2. Drug Master file
 Made by Kashish Wilson
 Assistant Professor,
 MM College of Pharmacy,
 MM(DU) Mullana,AMbala

3. INTRODUCTION:
Master Formula Record
 It is a document/set of documents specifying the starting
materials with their quantities and the packaging materials
,together with a description of the procedures and
precautions processing instructions including all the in-
process controls
 There shall be Master formula records related to all
manufacturing procedures for each product and batch size
to be manufactured .
 These shall be prepared and signed by competent technical
staff i.e. head of production and quality control

4. GMP guidelines on master documentation
Each of the regulation or guidelines below give a list of the requirements for content of the
Master file
 WHO: World Health Organization Technical Report Series, No. 908, 2003, Annex 4. Good
Manufacturing Practices for Pharmaceutical Products: Main Principles
 EU: EUDRALEX; Volume 4 - Medicinal Products for Human and Veterinary Use: Good
Manufacturing Practice: Chapter 4: Documentation.
 Pharmaceutical Inspection Convention (PIC): Pharmaceutical Inspection Co-operation
Scheme PE 009-3, 1 January 2006: Guide to Good Manufacturing Practice for Medicinal
Products. (© PIC/S January 2006)

5. Cont.
 And US FDA:
Guidance for Industry: Sterile Drug Products Produced by Aseptic
Processing — Current Good Manufacturing Practice. U.S. Department of
Health and Human Services, Food and Drug Administration, Center for
Drug Evaluation and Research (CDER), Center for Biologics Evaluation and
Research (CBER), Office of Regulatory Affairs (ORA), September 2004.
Pharmaceutical cGMPs.

6. INTRODUCTION to DMF
 Drug Master Files (DMFs): These are submissions to FDA used to
provide confidential, detailed information about facilities,
processes, or articles used in the manufacturing, processing,
packaging, and storing of human drug products.
 Allow parties to reference material without disclosing DMF
contents to those parties.
 Are not required by statute or regulation.
 Are neither approved nor disapproved. Instead, FDA reviews the
technical contents of DMFs in connection with the review of
applications that reference them (e.g., NDAs, ANDAs, INDs, BLAs).

7. Types of
Drug
Master
Files
Type I: Manufacturing site, facilities, operating
procedures, and personnel
Type II: Drug substance, drug substance intermediate,
and material used in their preparation, or drug product
Type III: Packaging material
Type IV: Excipient, colorant, flavor, essence, or
material used in their preparation
Type V: FDA accepted reference information