The document discusses drug master files (DMFs), which provide confidential manufacturing and facilities information to regulatory authorities. It covers:
1. DMFs are submitted voluntarily to regulatory agencies and contain detailed information about manufacturing processes, facilities, and components used in drugs.
2. They allow companies to protect intellectual property while ensuring regulatory disclosure, as when two firms partner in drug development or manufacturing.
3. Requirements for DMFs vary globally, with sections in the US, Europe, Canada, and Australia addressed in the presentation. Harmonization efforts aim to standardize DMF processes internationally.
This presentation gives an overview of the Drug Master File, a document submitted by the company or pharmaceutical industry to the regulatory authorities. It indicates that the company's product meets the desired quality standards. A brief introduction followed by types of DMF, its reviewing procedure and applications may give you a better understanding about Drug Master File.
This presentation covered the defination of dmf , importance of dmf filing , procedure of it , time period , requirement of dmf , letter of authorization meaning ,content of dmf , types of dmf
This presentation gives an overview of the Drug Master File, a document submitted by the company or pharmaceutical industry to the regulatory authorities. It indicates that the company's product meets the desired quality standards. A brief introduction followed by types of DMF, its reviewing procedure and applications may give you a better understanding about Drug Master File.
This presentation covered the defination of dmf , importance of dmf filing , procedure of it , time period , requirement of dmf , letter of authorization meaning ,content of dmf , types of dmf
Disclaimer:
I have created this document with inputs from various sources. Some are taken right from slideshare. I just try to make this topic little compact and lucid, so that everybody can understand it easily
I am very much thankful to the original authors also, don't think I am just doing plagarism.
Herbal medicines are popular because of experience and the abundant
availability of plants in India due to its varied climatic zones. India has
around 45,000 species of plants, out of which 15,000–20,000 plants have
proven medicinal value.
The dossier is a collection of documents that contain all the technical data of pharmaceutical products to be approved\ registered\ marketed in a country.
I. INTRODUCTION
II. DEFINITIONS
III. TYPES OF DRUG MASTER FILES
IV. SUBMISSIONS TO DRUG MASTER FILES
V. AUTHORIZATION TO REFER TO A DRUG MASTER FILE
VI. PROCESSING AND REVIEWING POLICIES
VII. HOLDER OBLIGATIONS
IX. CLOSURE OF A DRUG MASTER FILE.
Disclaimer:
I have created this document with inputs from various sources. Some are taken right from slideshare. I just try to make this topic little compact and lucid, so that everybody can understand it easily
I am very much thankful to the original authors also, don't think I am just doing plagarism.
Herbal medicines are popular because of experience and the abundant
availability of plants in India due to its varied climatic zones. India has
around 45,000 species of plants, out of which 15,000–20,000 plants have
proven medicinal value.
The dossier is a collection of documents that contain all the technical data of pharmaceutical products to be approved\ registered\ marketed in a country.
I. INTRODUCTION
II. DEFINITIONS
III. TYPES OF DRUG MASTER FILES
IV. SUBMISSIONS TO DRUG MASTER FILES
V. AUTHORIZATION TO REFER TO A DRUG MASTER FILE
VI. PROCESSING AND REVIEWING POLICIES
VII. HOLDER OBLIGATIONS
IX. CLOSURE OF A DRUG MASTER FILE.
A Drug Master File (DMF) is a confidential submission to the FDA containing detailed information about the manufacturing, processing, packaging, and storing of a pharmaceutical product. It is submitted by a drug manufacturer to support a regulatory application, such as a New Drug Application (NDA) or an Abbreviated New Drug Application (ANDA), without disclosing the information to the applicant. The DMF system helps streamline the regulatory review process while protecting proprietary information.
DRUG MASTER FILE
Presented by :
RUSHIKESH D MENDHE
Roll no - 511
Mpharm Ist Year
(Department of Pharmaceutics)
Content : :
INTRODUCTION
TYPES OF DMF
DMF FORMAT & ASSEMBLY
DELIVERY OF DMF TO FDA
SUBMISSION OF DMF
THE MECHANISM OF A DRUG MASTER FILE
CTD & ELECTRONIC DMFS
UPDATES TO DMF
CLOSURE OF A DRUG MASTER FILE
APPLICATION OF DMF
REFERENCE
INTRODUCTION :
A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.
This guideline does not impose mandatory requirements.
Objectives :
Main Objective of the DMF is to support regulatory requirements
To prove the quality, safety and efficacy of the medicinal product
TYPES OF DMF :
DMF FORMAT & ASSEMBLY :
The DMF is submitted as Original and Duplicate jackets, collated, assembled, paginated, and jacketed, using covers obtained from the government printing office and a respecifically provided for the DMFs
Multiple volumes are numbered, and the paper must be standard paper size
Paper length should not be less than 10 inches nor more than 12 inches.
Each volume of a DMF should be not more than 2 inches thick
DELIVERY OF DMF TO FDA :
DMF should be submitted at following address :
Food and Drug Administration Center for Drug Evaluation and Research Central Document Room 5901 – B Ammendale Road Beltsville, MARYLAND 20705-1266 USA
SUBMISSION OF DMF :
The DMF must be submitted in two copies, one with a blue cover and one with a red cover.
Each page of each copy of the DMF should be dated and consecutively numbered.
Each DMF submission should contain :
• A Transmittal letter
• Administrative information about the submission
• Other specific information
A. Transmittal Letter :
i) Original Submissions :
• Identification of submission: Original, the type of DMF as classified in Section III, and its subject.
• Identification of the applications, if known, that the DMF is intended to support, including the name and address of each sponsor, applicant, or holder, and all relevant document numbers.
• Signature of the holder or the authorized representative.
• Typewritten name and title of the signer.
ii) Ammendments :
• Identification of submission: Amendment, the DMF number, type of DMF, and the subject of the amendment.
• A description of the purpose of submission, e.g., update, revised formula, or revised process.
• Signature of the holder or the authorized representative.
• Typewritten name and title of the signer.
B. Administrative information about the submission:
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Learning objectives:
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4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
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The Central Drugs Standard Control Organization (CDSCO) is India's national regulatory body for pharmaceuticals and medical devices. Operating under the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India, the CDSCO is responsible for approving new drugs, conducting clinical trials, setting standards for drugs, controlling the quality of imported drugs, and coordinating the activities of State Drug Control Organizations by providing expert advice.
Pharmacovigilance, on the other hand, is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. The primary aim of pharmacovigilance is to ensure the safety and efficacy of medicines, thereby protecting public health.
In India, pharmacovigilance activities are monitored by the Pharmacovigilance Programme of India (PvPI), which works closely with CDSCO to collect, analyze, and act upon data regarding adverse drug reactions (ADRs). Together, they play a critical role in ensuring that the benefits of drugs outweigh their risks, maintaining high standards of patient safety, and promoting the rational use of medicines.
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Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
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DRUG MASTER FILE AND GLOBAL REGULATORY REQUIREMENTS
1. NAILA KANWAL
Sr. Officer Regulatory Affairs
The SEARLE Company Limited
DRUG MASTER FILE (DMF)
&
Global Regulatory Requirements
2. Drug Master Fileor DMF is a document
prepared by a pharmaceutical manufacturer
and submitted solely at its discretion to the
appropriate regulatory authority in the
intended drug market.
The document provides the regulatory
authority with confidential, detailed
information about facilities, processes, or
articles used in the manufacturing, processing,
packaging, and storing of one or more human
drugs.
Prepared By : Naila Kanwal
Slide
2
3. Typically, a DMF is filed when two or more
firms work in partnership on developing or
manufacturing a drug product.The DMF
filing allows a firm to protect
its intellectual property from its partner
while complying with regulatory
requirements for disclosure of processing
details.
Prepared By : Naila Kanwal Slide
3
5. Prepared By : Naila Kanwal Slide
5
1.
The DMF
contains factual
and complete
information on a
drug product's
chemistry,
2-
Manufacture
4-
Purity
3-
Stability 6-
Packaging.
5-
Impurit
y
profile,
6. Prepared By : Naila Kanwal Slide
6
C. CHARACTERISATION
1. Eluciation of
Structure and other
characteristics
A. GENERAL
INFORMATION
B. 1. General
properties
2. Structure
3. Nomenclature
C. CHARACTERISATION
1. Elucidation of
Structure and other
characteristics
2. Impurities
a) Sources of
Potential Impurities.
b)Types of
impurities. c)Test
Procedure for
determining
impurities
B. MANUFACTURE
1. Manufacture(s)
2. Description of Manufacturing
Process and ProcessControl a)
Flow Chart of Manufacturing
Process b) Synthetic Route of
Manufacturing Process c)
Manufacturing Method.
3. Control of Material a) List of
Materials. b) Specification and
routine tests of the Raw Materials.
4. Control of Critical Steps and
Intermediates.
a) Critical Steps. b) Process
Validation and/or evaluation.
5. Specifications andTest method for
the Intermediates.
6. Manufacturing
ProcessDevelopment
7. Prepared By : Naila Kanwal Slide
7
E. REFERENCE STANDARDSOF MATERIAL
F. CONTAINER CLOSURE SYSTEM
G. STABILITY
1. Stability summary and
Conclusions
2. Post-Approval Stability protocol
and Stability Commitment.
3. Stability data
a) Accelerated Stability
b) LongTerm Stability Studies
c) Forced Degradation Studies
H. MATERIAL DATA SAFETY
SHEET
I. APPENDICES
1. FACILITIES AND
EQUIPMENTS
a) Building and Utilities
2. EQUIPMENTS DESIGN
AND
LOCATION
a. Equipment List
b. Equipment Flow
Chart
3. ADVENTITIOUSAGENTS
SAFETY EVALUATIONS
STATEMENT OF COMMENT
D. CONTROLOF
DRUG SUBSTANCES
1. Specifications
2. Analytical
procedure
3.Validation of
Analytical
procedure
4. Batch Analysis
a) Description of
Batches
b) Certificate of
Analysis
5. Justification of
Specification
9. DMFs in the United States
Prepared By : Naila Kanwal Slide
9
10. 1-DMFs in the United States
In the United States, DMFs are submitted to the
Food and Drug Administration FDA).
The Main Objective of the DMF is to support
regulatory requirements and to prove the quality,
safety and efficacy of the medicinal product for
obtaining an Investigational New Drug Application
(IND), a New Drug Application (NDA),As an
Abbreviated New Drug Application (ANDA), another
DMF, or an Export Application.
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10
11. A US: drug master file comprises two parts:
The Applicant’s Part
1- (USA: Open Part)
Which contains all the information that the licence-
holder needs to assess the quality and submit a
licence or amendment application.
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11
12. 2- Restricted Part (USA: Closed Part):
Which contains confidential information about
the manufacturing procedure only disclosed to
the authorities.
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12
14. Prepared By : Naila Kanwal Slide
14
TYPES OF DMFs
The types of DMFs are:
Type I :
Manufacturing Site, Facilities, Operating
Procedures, and Personnel (no longer applicable).
Type II :
Drug Substance, Drug Substance Intermediate, and
Material Used inTheir Preparation, or Drug Product.
15. Prepared By : Naila Kanwal Slide
15
TYPES OF DMFs
Type III :
Packaging Material.
Type IV :
Excipient, Colorant, Flavor, Essence, or Material
Used inTheir Preparation.
TypeV :
FDA Accepted Reference Information.
16. Prepared By : Naila Kanwal Slide
16
2- DMFs in Europe
17. Prepared By : Naila Kanwal Slide
17
DMFs in Europe
The content and the format for drug master file
used in United States differs from that used in
European Countries to obtain market authorization
(MA).The Main Objective of the EDMF is to support
regulatory requirements of a medicinal product to
prove its quality, safety and efficacy.This helps to
obtain a Marketing authorisation grant.
18. Prepared By : Naila Kanwal Slide
18
The DMF contains information which includes valuable
know-how which should be kept confidential and
submitted to the authorities only.
Therefore, it should be divided into 2 parts – an
applicant’s part and an ASM Restricted Part.
The applicant’s part of a DMF is provided by the ASM
(Active Substance Manufacturer) to the applicant
directly and becomes part of the application for
marketing authorization. Both the applicant’s part and
the ASM Restricted Part of the DMF are submitted to
the authorities.
19. Prepared By : Naila Kanwal Slide
19
Applicant’s part of a DMF – opening part
The applicant must be supplied by the ASM with sufficient
information to be able to take responsibility for an
evaluation of the suitability of the active substance
specification to control the quality of the substance.This
normally includes a brief outline of the manufacturing
method, information on potential impurities originating
from the manufacturing method, from the isolation
procedure (natural products) or from degradation and,
where applicable, information on the toxicity of specific
impurities.
20. Prepared By : Naila Kanwal Slide
20
ASM Restricted Part of DMF – closing part
Detailed information on the individual steps of the
manufacturing method such as reaction conditions,
temperature, validation and evaluation data for certain
critical steps of the manufacturing method, etc. and on
quality control during manufacture may contain valuable
know-how. Such information may therefore be supplied
to the authorities only.
21. Prepared By : Naila Kanwal Slide
21
Other DMF Systems:
1- Canada
2- Australia
22. 3-DMFs in Canada:
Canada has 4Types of DMFs,
Type 1: Used for Active Pharmaceutical
Ingredients (APIs)
Type II: used for packaging materials
Type III: used for excipients
Type IV: used for products
Prepared By : Naila Kanwal Slide
22
23. 3-DMFs in Canada:
Type I & 4 have two sections
Sponsor's (Open)
Restricted (Closed)
Prepared By : Naila Kanwal Slide
23
24. 4-DMFs in Australia:
In the case of an API used by a
producer for a medicine who’s origin is
a third party manufacturer, data about
its fabrication, quality control and
stability can be presented by a Drug
Master File (DMF).
Prepared By : Naila Kanwal Slide
24
25. 4-DMFs in Australia:
The Europena style relavent for the procedure of
a Active Substance Master File, adopted by
Austrailia’s Therapeutic Goods Administration
(TGA), are available on theTGA website.
A DMF format used by the US (FDA) is
acceptable if the DMF is prepared according to
the CommonTechnical Document (CTD) format
or the older European format if this is not
available.
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25