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:
A brief presentation on the Code of Federal Regulations
Covers the following aspects -
- What is CFR?
-History of CFR
- CFR Title 21
- CFR in modern times.
- Research tools in CFR
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 brief presentation on the Code of Federal Regulations
Covers the following aspects -
- What is CFR?
-History of CFR
- CFR Title 21
- CFR in modern times.
- Research tools in CFR
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.
- Whilst the realization of the CTD took many years, there is now a common format for the submission of Marketing Authorizations Applications across the three ICH regions - Europe, Japan and the USA.
- This should facilitate pharmaceutical companies to make simultaneous filings in the ICH regions as it will eliminate the extensive work previously required to convert, for example, a US dossier to an EU dossier and vice versa.
COPP/CPP it certification of pharmaceutical product for reviewing QSE i.e. Quality, Sefty,Efficacy of product. it important certification for exporting it may required by importing country.
Abbreviated New Drug Application [ANDA]Sagar Savale
An Abbreviated New Drug Application (ANDA) contains data which when submitted to FDA's CDER, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product.
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.
- Whilst the realization of the CTD took many years, there is now a common format for the submission of Marketing Authorizations Applications across the three ICH regions - Europe, Japan and the USA.
- This should facilitate pharmaceutical companies to make simultaneous filings in the ICH regions as it will eliminate the extensive work previously required to convert, for example, a US dossier to an EU dossier and vice versa.
COPP/CPP it certification of pharmaceutical product for reviewing QSE i.e. Quality, Sefty,Efficacy of product. it important certification for exporting it may required by importing country.
Abbreviated New Drug Application [ANDA]Sagar Savale
An Abbreviated New Drug Application (ANDA) contains data which when submitted to FDA's CDER, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product.
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.
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.
A Drug Master File (DMF) is a submission to the USFDA or to the concerned regulatory authority, 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 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
Nutraceutical market, scope and growth: Herbal drug technologyLokesh Patil
As consumer awareness of health and wellness rises, the nutraceutical market—which includes goods like functional meals, drinks, and dietary supplements that provide health advantages beyond basic nutrition—is growing significantly. As healthcare expenses rise, the population ages, and people want natural and preventative health solutions more and more, this industry is increasing quickly. Further driving market expansion are product formulation innovations and the use of cutting-edge technology for customized nutrition. With its worldwide reach, the nutraceutical industry is expected to keep growing and provide significant chances for research and investment in a number of categories, including vitamins, minerals, probiotics, and herbal supplements.
A brief information about the SCOP protein database used in bioinformatics.
The Structural Classification of Proteins (SCOP) database is a comprehensive and authoritative resource for the structural and evolutionary relationships of proteins. It provides a detailed and curated classification of protein structures, grouping them into families, superfamilies, and folds based on their structural and sequence similarities.
Earliest Galaxies in the JADES Origins Field: Luminosity Function and Cosmic ...Sérgio Sacani
We characterize the earliest galaxy population in the JADES Origins Field (JOF), the deepest
imaging field observed with JWST. We make use of the ancillary Hubble optical images (5 filters
spanning 0.4−0.9µm) and novel JWST images with 14 filters spanning 0.8−5µm, including 7 mediumband filters, and reaching total exposure times of up to 46 hours per filter. We combine all our data
at > 2.3µm to construct an ultradeep image, reaching as deep as ≈ 31.4 AB mag in the stack and
30.3-31.0 AB mag (5σ, r = 0.1” circular aperture) in individual filters. We measure photometric
redshifts and use robust selection criteria to identify a sample of eight galaxy candidates at redshifts
z = 11.5 − 15. These objects show compact half-light radii of R1/2 ∼ 50 − 200pc, stellar masses of
M⋆ ∼ 107−108M⊙, and star-formation rates of SFR ∼ 0.1−1 M⊙ yr−1
. Our search finds no candidates
at 15 < z < 20, placing upper limits at these redshifts. We develop a forward modeling approach to
infer the properties of the evolving luminosity function without binning in redshift or luminosity that
marginalizes over the photometric redshift uncertainty of our candidate galaxies and incorporates the
impact of non-detections. We find a z = 12 luminosity function in good agreement with prior results,
and that the luminosity function normalization and UV luminosity density decline by a factor of ∼ 2.5
from z = 12 to z = 14. We discuss the possible implications of our results in the context of theoretical
models for evolution of the dark matter halo mass function.
The increased availability of biomedical data, particularly in the public domain, offers the opportunity to better understand human health and to develop effective therapeutics for a wide range of unmet medical needs. However, data scientists remain stymied by the fact that data remain hard to find and to productively reuse because data and their metadata i) are wholly inaccessible, ii) are in non-standard or incompatible representations, iii) do not conform to community standards, and iv) have unclear or highly restricted terms and conditions that preclude legitimate reuse. These limitations require a rethink on data can be made machine and AI-ready - the key motivation behind the FAIR Guiding Principles. Concurrently, while recent efforts have explored the use of deep learning to fuse disparate data into predictive models for a wide range of biomedical applications, these models often fail even when the correct answer is already known, and fail to explain individual predictions in terms that data scientists can appreciate. These limitations suggest that new methods to produce practical artificial intelligence are still needed.
In this talk, I will discuss our work in (1) building an integrative knowledge infrastructure to prepare FAIR and "AI-ready" data and services along with (2) neurosymbolic AI methods to improve the quality of predictions and to generate plausible explanations. Attention is given to standards, platforms, and methods to wrangle knowledge into simple, but effective semantic and latent representations, and to make these available into standards-compliant and discoverable interfaces that can be used in model building, validation, and explanation. Our work, and those of others in the field, creates a baseline for building trustworthy and easy to deploy AI models in biomedicine.
Bio
Dr. Michel Dumontier is the Distinguished Professor of Data Science at Maastricht University, founder and executive director of the Institute of Data Science, and co-founder of the FAIR (Findable, Accessible, Interoperable and Reusable) data principles. His research explores socio-technological approaches for responsible discovery science, which includes collaborative multi-modal knowledge graphs, privacy-preserving distributed data mining, and AI methods for drug discovery and personalized medicine. His work is supported through the Dutch National Research Agenda, the Netherlands Organisation for Scientific Research, Horizon Europe, the European Open Science Cloud, the US National Institutes of Health, and a Marie-Curie Innovative Training Network. He is the editor-in-chief for the journal Data Science and is internationally recognized for his contributions in bioinformatics, biomedical informatics, and semantic technologies including ontologies and linked data.
1. Presented by :
RUSHIKESH D MENDHE
Roll no - 511
Mpharm Ist Year
(Department of Pharmaceutics)
1
Guided by :
Dr. (Mrs.) PALLAVI M.
CHAUDHARI
Dr. D.Y Patil College of Pharmacy
Akurdi,Pune
2. 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 2
3. 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.
3
4. Objectives :
Main Objective of the DMF is to support regulatory
requirements
To prove the quality, safety and efficacy of the
medicinal product
4
5. TYPES OF DMF :DMF
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
5
6. General Points Include In Type II DMF
Manufacturing
Sections
Quality
Controls
Input
(Raw/Packaging
Materials)
Intermediates & In
process
Finished Drug
Substances
Validation
Stability
Data
Impurities
Packaging
&
Labelling
6
7. 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 7
8. 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
8
9. 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) A Transmittal letter
b) Administrative information about the submission
c) Other specific information
9
10. 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.
10
11. B. Administrative information about the
submission:
i) Original Submissions :
Names and addresses of the following:
- DMF holder.
- Corporate headquarters.
- Manufacturing/processing facility.
- Contact for FDA correspondence.
- Agent(s), if any.
The specific responsibilities of each person listed in any of the
categories in Section a.
Statement of commitment.
A signed statement by the holder certifying that the DMF is
current and that the DMF holder will comply with the
statements made in it.
11
12. ii) Amendments
Name of DMF holder.
DMF number.
Name and address for correspondence.
Affected section and/or page numbers of the DMF.
The name and address of each person whose IND, NDA,
ANDA, DMF, or Export Application relies on the subject of
the amendment for support.
The number of each IND, NDA, ANDA, DMF, and Export
Application that relies on the subject of the amendment for
support, if known.
Particular items within the IND, NDA, ANDA, DMF, and
Export Application that are affected, if known.
12
13. The Mechanism of a Drug Master File:
A DMF goes through two stages : First, FDA assesses
whether all parts of the DMF are included and in the
correct order. Once FDA determines that the eDMF is
acceptable, it will then undergo an administrative
review as discussed above.
If the DMF is not acceptable, the holder will be
informed.
The holder must then satisfactorily respond to any
deficiencies for the DMF
13
14. If the DMF passes the administrative review and is
found to be acceptable, Office of Pharmaceutical
Quality (OPQ) sends an Acknowledgement Letter for
review of the technical content.
However, if the DMF is not acceptable from an
administrative point of view, OPQ sends an
Administrative Filing Issues (AFI) letter.
The required time for this could be from 2-3 weeks.
14
15. CTD & Electronic DMFs :
The CTD(Common Technical Documents) is organized
into five modules, those are:
Module 1 : References regional information such as forms,
cover letter, labeling, and investigational brochures
Module 2 : Quality Overall Summary
Module 3 : Quality
Module 4 : Non-clinical information
Module 5 : Clinical information
• Once a DMF has been submitted in electronic form no
paper documnts to be submitted.
15
16. UPDATES TO DMF :
DMF are to update by annually, the updates shall be
reported as “Annual Report”, and the annual report
date will be from on the anniversary date of the
original submission.
Failure to submit an Annual report to the DMF in past
three years, FDA will send “Overdue Notification
Letters” (ONLs) to DMF holder.
If a DMF holder does not respond to this letter within
90 days with the submission of an Annual Report, the
DMF may be closed by the FDA.
16
17. CLOSURE OF A DRUG MASTER FILE :
A holder who wishes to close a DMF should submit a
request to the Drug Master File Staff stating the reason
for the closure.
The Agency may close a DMF that does not contain an
annual update of persons authorized to incorporate
information in the DMF by reference and a list of
changes made since the previous annual report. The
holder will be notified of FDA's intent to close the
DMF.
17
18. Application of DMF :
The DMF can be referenced by drug manufacturers in
support of their NDAs, ANDAs and clinical trial
applications
Maintain confidentiality of proprietary information (e.g.,
Manufacturing procedure) for the holder
Permit review of information by reviewers in the Center for
Drug Evaluation and Research( CDER) to support
applications submitted by one or more applicants
18
19. REFERENCE :
Yehaskel Albert, An Overview of Drug Master Files,
Pharmaceut Regulatory Affairs 2018, Vol 7,Issue-1; 190 – 198
S. Anusha, N.V.N. Mounica, V. Sharmila, S. Sravika, M. V.
Nagabhushanam,Reddy Nagarjuna, ‘Processing And
Submission Of Drug Master File’, World Journal of
Pharmacy and Pharmaceutical Sciences, Volume 6, Issue 3,
356-366
Official site of FDA - https://www.fda.gov/drugs/forms-
submission-requirements/drug-master-files-dmfs
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