What is drug master file?
Drug master file (DMF) is set of documents submitted to food and drugs administration (FDA) by pharma manufacturer, the drug master file may also provide information which may be confidential for the company but may be required to be presented to regulatory authority for complete understanding of their product, facility, and the processes, systems, equipments and articles adapted for various of process of manufacturing and quality control and quality assurance, or storage and distribution.
A holder can permit or authorize other person to rely on data and information for various applications submissions.
It is not mandatory document for US FDA, but it is submitted by a pharmaceutical manufacturer to support their export application or (ANDA) Abbreviated New Drug Application, IND Investigational New Drug Application , or (NDA) New Drug Application. FDA reviews DMF only in context with these applications and an application for marketing a new drug in market.
These applications may reference the content to DMF wherever it is applicable. The drug master file is submitted to FDA in two copies, one copy must be retained by the person or holder who is submiting DMF.
US FDA classifies Drug master file DMF in to five types:
Type I
DMF provides information about manufacturing facility or Site, technical personnel’s working for the company and Operating Procedures.
This type of Drug master file DMF is required from conducting on site inspections out side of USA
It should describe
1. Site of manufacturing, actual address of site , and a map showing its geographical location.
2. Operational layout, with diagram of main processing or production arias.
3. Equipments and capabilities. Complete description about equipment capabilities and their applications.
Organization diagram, highlighting key on site and corporate Quality control and Quality assurance positions.
Type II
Type II Drug master file give information about drug molecule, its Intermediates, and starting material and intermediates used in the manufacturing of drug molecule and drug product.
For each packaging material complete information about their use, composition and components, and how they are controlled and released.
Details about name of supplier, their manufacturer too are required to be provided.
If required by drug product, one should also provide toxicological data about packaging material.
Type III
Drug master file provides information about packaging material used for packaging drug product.
Type IV
Provides information about colorants additives, exceipients and flavors essences or substances used for manufacturing them.
Type V
Contains the information references which are accepted by FDA.It is required that a DMF to provide only one type of information and all data to support, different DMF’s may be cross referenced amongst themselves.
Though US FDA does not make it a mandatory document for any approval or disapproval , they have provided guidelines in section 21CFR314.420 about how DMF should be prepared and submitted .
21CFR314.420 states that a Drug master fileDMF for application in support of application for approval for marketing a new drug in market. should provide information about
1.) Drug molecule
2.) Drug molecule intermediates
3.) Packaging materials
4.) Excipients
5.) Flavors
6.) Essence
7.) Colorants
8.) Or substances used to make them
9.) It also states that it should also provide complete list of persons who are authorized to incorporate any change in the DMF, and DMF holder may restrict a person to only a particular drug product.
10.) Stability data of drug product.
Different terms used for Drug master file
For submit ion to European countries it is called as Active Substance Master File (ASMF) European Drug Master File (EDMF) and it is also called US-Drug Master file (US-DMF) in United States.
Also see
Do Physical properties contribute to drug activity.
What is drug receptor , How a drug resistance occurs
Mechanism of drug resistance
What is drug interaction
Drug interaction, and its examples
What is first pass metabolism of a drug
What is 510(k) Clearances,
Premarket Notification for medical devices - PMN or 510(k)
What is a drug interaction
Examples of drug interactions
Antibiotic Definition and classification
Antibiotic resitance and Antibiotic resistance mechanism
Antioxidants food suppliments
Vitamin D Details on FDA cautions on accurate dosage of Vitamin D
What is an antibody? what is monoclonal and polyclonal antibodies?
Terminologies In vaccine Production
Multi stage testing of Virus vaccine production
Testing of vaccines at different stages of production
TESTING FOR ADVENTITIOUS AGENTS CELL PROPERTIES IN VIRAL VACCINE PRODUCTION
Enzyme linked immunosorbent assay ELISA
Raido Immuno assay
pharmaceutical industry
Pharmaceutical Validation
Types of validations in pharmaceutical manufacturing
Requirements of documents for validation of sterilisation process
How to investigate OOS out of specification results
Determination of Phenol coefficient of a disinfectant
Sterility testing
Cleen Room Classification
Time limitations in sterile pharmaceuticals processing
Aspects of validation of manufacturing process in sterile pharmaceuticals
Clinical Trials
Controlling Pyrogens in injectable dosage forms
Media fill run process simulation aspects Validation of Aseptic Process and Sterilisation
New Drug Application (NDA) how to make a New Drug Application (NDA) to US FDA
Abbreviated New Drug Application (ANDA) What is ANDA , detaied information about ANDA preparation and submission to US FDA
How to make Investigational New Drug (IND) Application to US FDA
Drug applications submission to us fda Over the counter Drugs OTC drugs
BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS
Electronic record in pharmaceutical manufacturing industry
Quality by designe concept for pharmaceutical industry
Quality by designe concept in pharmaceutical industryan explanation
Drug master file (DMF) is set of documents submitted to food and drugs administration (FDA) by pharma manufacturer, the drug master file may also provide information which may be confidential for the company but may be required to be presented to regulatory authority for complete understanding of their product, facility, and the processes, systems, equipments and articles adapted for various of process of manufacturing and quality control and quality assurance, or storage and distribution.
A holder can permit or authorize other person to rely on data and information for various applications submissions.
It is not mandatory document for US FDA, but it is submitted by a pharmaceutical manufacturer to support their export application or (ANDA) Abbreviated New Drug Application, IND Investigational New Drug Application , or (NDA) New Drug Application. FDA reviews DMF only in context with these applications and an application for marketing a new drug in market.
These applications may reference the content to DMF wherever it is applicable. The drug master file is submitted to FDA in two copies, one copy must be retained by the person or holder who is submiting DMF.
US FDA classifies Drug master file DMF in to five types:
Type I
DMF provides information about manufacturing facility or Site, technical personnel’s working for the company and Operating Procedures.
This type of Drug master file DMF is required from conducting on site inspections out side of USA
It should describe
1. Site of manufacturing, actual address of site , and a map showing its geographical location.
2. Operational layout, with diagram of main processing or production arias.
3. Equipments and capabilities. Complete description about equipment capabilities and their applications.
Organization diagram, highlighting key on site and corporate Quality control and Quality assurance positions.
Type II
Type II Drug master file give information about drug molecule, its Intermediates, and starting material and intermediates used in the manufacturing of drug molecule and drug product.
For each packaging material complete information about their use, composition and components, and how they are controlled and released.
Details about name of supplier, their manufacturer too are required to be provided.
If required by drug product, one should also provide toxicological data about packaging material.
Type III
Drug master file provides information about packaging material used for packaging drug product.
Type IV
Provides information about colorants additives, exceipients and flavors essences or substances used for manufacturing them.
Type V
Contains the information references which are accepted by FDA.It is required that a DMF to provide only one type of information and all data to support, different DMF’s may be cross referenced amongst themselves.
Though US FDA does not make it a mandatory document for any approval or disapproval , they have provided guidelines in section 21CFR314.420 about how DMF should be prepared and submitted .
21CFR314.420 states that a Drug master fileDMF for application in support of application for approval for marketing a new drug in market. should provide information about
1.) Drug molecule
2.) Drug molecule intermediates
3.) Packaging materials
4.) Excipients
5.) Flavors
6.) Essence
7.) Colorants
8.) Or substances used to make them
9.) It also states that it should also provide complete list of persons who are authorized to incorporate any change in the DMF, and DMF holder may restrict a person to only a particular drug product.
10.) Stability data of drug product.
Different terms used for Drug master file
For submit ion to European countries it is called as Active Substance Master File (ASMF) European Drug Master File (EDMF) and it is also called US-Drug Master file (US-DMF) in United States.
Also see
Do Physical properties contribute to drug activity.
What is drug receptor , How a drug resistance occurs
Mechanism of drug resistance
What is drug interaction
Drug interaction, and its examples
What is first pass metabolism of a drug
What is 510(k) Clearances,
Premarket Notification for medical devices - PMN or 510(k)
What is a drug interaction
Examples of drug interactions
Antibiotic Definition and classification
Antibiotic resitance and Antibiotic resistance mechanism
Antioxidants food suppliments
Vitamin D Details on FDA cautions on accurate dosage of Vitamin D
What is an antibody? what is monoclonal and polyclonal antibodies?
Terminologies In vaccine Production
Multi stage testing of Virus vaccine production
Testing of vaccines at different stages of production
TESTING FOR ADVENTITIOUS AGENTS CELL PROPERTIES IN VIRAL VACCINE PRODUCTION
Enzyme linked immunosorbent assay ELISA
Raido Immuno assay
pharmaceutical industry
Pharmaceutical Validation
Types of validations in pharmaceutical manufacturing
Requirements of documents for validation of sterilisation process
How to investigate OOS out of specification results
Determination of Phenol coefficient of a disinfectant
Sterility testing
Cleen Room Classification
Time limitations in sterile pharmaceuticals processing
Aspects of validation of manufacturing process in sterile pharmaceuticals
Clinical Trials
Controlling Pyrogens in injectable dosage forms
Media fill run process simulation aspects Validation of Aseptic Process and Sterilisation
New Drug Application (NDA) how to make a New Drug Application (NDA) to US FDA
Abbreviated New Drug Application (ANDA) What is ANDA , detaied information about ANDA preparation and submission to US FDA
How to make Investigational New Drug (IND) Application to US FDA
Drug applications submission to us fda Over the counter Drugs OTC drugs
BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS
Electronic record in pharmaceutical manufacturing industry
Quality by designe concept for pharmaceutical industry
Quality by designe concept in pharmaceutical industryan explanation
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