DMF (Drug Master File) and CTD (Common Technical Document)
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Drug DMF and CTD Compliance: Essential Insights for Your Business
DMF (Drug Master File) and CTD (Common Technical Document) are structured regulatory documents essential for pharmaceutical market approval, providing comprehensive details on drug substances, formulation, manufacturing processes, quality control, and safety data to ensure compliance with global regulatory standards.
(QSR).
As fundamental components of pharmaceutical regulatory submissions, DMF and CTD streamline the approval process across multiple markets. However, due to varying regulatory requirements in different countries, modifications may be necessary to align with specific national standards. Our expertise in global pharmaceutical regulations ensures seamless adaptation, helping you navigate market-specific requirements efficiently.
KGMP Drug DMF & CTD Service
Key Stage of DMF and CTD
The Drug Master File (DMF) and Common Technical
Document (CTD) are often used interchangeably or misinterpreted, leading to
confusion and regulatory non-compliance. While both documents play a crucial
role in supporting pharmaceutical manufacturers in meeting regulatory
requirements and ensuring product safety, each serves a distinct function in
drug approval processes.
Our specialists assist in preparing and reviewing DMF
and CTD documentation in accordance with extensive regulatory guidance from
authorities in your target market. With our expert evaluations, you can
streamline the approval process, ensuring compliance with global standards.
Leveraging our deep expertise in international regulations, we help consolidate
country-specific requirements into a comprehensive and efficient document,
optimizing your regulatory strategy for seamless market entry.
DMF (Drug Master File)
A Drug Master File (DMF) is an independent document
containing detailed information on active pharmaceutical ingredients (APIs),
manufacturing processes, quality control (QC), and stability. It is submitted
by API manufacturers and registered with regulatory authorities such as the FDA
and EMA, allowing drug product applicants to reference it in their submissions.
DMF submission requirements and review processes vary by country. Accurate
preparation and submission of a DMF are critical to preventing approval delays
and ensuring smooth market access.
Q1) Type of DMFs
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Type I: Manufacturing Site, Facilities, Operating Procedures, and Personnel
This type includes information about the manufacturing
site, facilities, operating procedures, and personnel involved in the
production process. It provides an overview of the operational capabilities and
resources necessary for the manufacturing of the drug substance or product.
Type II: Drug Substance, Drug Substance Intermediate,
and Material Used in Their Preparation; or Drug Product
Type II covers details related to the drug substance,
including intermediates and raw materials used in its preparation. It also
includes information about the drug product, such as formulation, manufacturing
processes, and quality control measures for both the drug substance and the
final product.
Type III: Packaging Material
This type includes information about the materials
used for packaging the drug product. It covers details on the composition,
quality control, and specifications of packaging materials to ensure product
stability and integrity.
Type IV: Excipient, Colorant, Flavor, Essence, or
Material Used in Their Preparation
Type IV focuses on excipients, colorants, flavorings,
essences, or other materials used in the preparation of the drug substance or
product. It includes data on the identity, quality, and quantity of these
components to ensure their safety and compliance with regulatory standards.
Type V: Accepted Reference Information
Type V consists of accepted reference information,
such as master files or other references previously approved by regulatory
authorities. It provides supplementary information that may support the safety,
quality, or efficacy of the drug substance or product based on prior
submissions or approvals.
This type includes information about the manufacturing site, facilities, operating procedures, and personnel involved in the production process. It provides an overview of the operational capabilities and resources necessary for the manufacturing of the drug substance or product.
Type II: Drug Substance, Drug Substance Intermediate,
and Material Used in Their Preparation; or Drug Product
Type II covers details related to the drug substance,
including intermediates and raw materials used in its preparation. It also
includes information about the drug product, such as formulation, manufacturing
processes, and quality control measures for both the drug substance and the
final product.
Type III: Packaging Material
This type includes information about the materials used for packaging the drug product. It covers details on the composition, quality control, and specifications of packaging materials to ensure product stability and integrity.
Type IV: Excipient, Colorant, Flavor, Essence, or
Material Used in Their Preparation
Type IV focuses on excipients, colorants, flavorings, essences, or other materials used in the preparation of the drug substance or product. It includes data on the identity, quality, and quantity of these components to ensure their safety and compliance with regulatory standards.
Type V: Accepted Reference Information
Type V consists of accepted reference information, such as master files or other references previously approved by regulatory authorities. It provides supplementary information that may support the safety, quality, or efficacy of the drug substance or product based on prior submissions or approvals.
Q2) DMF Contents
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A. Confidential Part
A. Confidential Part
ㆍ Manufacturer
ㆍ Manufacturing
facility and GMP
ㆍ Description
of the manufacturing process and process controls
ㆍ Control
of materials
ㆍ US
Agent appointment and authorization
ㆍ Owner/operator contact information
B. Non-confidential Part
ㆍ General information
ㆍ Specification
ㆍ Control of critical steps and intermediates
ㆍ Process validation and/or evaluation
ㆍ Manufacturing process development
ㆍ Material Characterization
ㆍ Quality Control
ㆍ Reference standards or materials
ㆍ Container closure system
ㆍ Stability
ㆍ Shelf-life
Q3) DMF Life-cycle Management
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ㆍ Preparation
and submission of annual reports
ㆍ Preparation
and submission of amendments
ㆍ Response
to queries to facilitate the approval of amendment filings
CTD (Common Technical Document)
The Common Technical Document (CTD) is an
internationally recognized standard format for drug approval submissions,
established by the International Council for Harmonization (ICH). The CTD
format is adopted by major regulatory authorities, including the FDA (U.S.),
EMA (Europe), and PMDA (Japan), and serves to enhance the efficiency of the
drug review process while standardizing submission documents. The electronic
version, eCTD, is increasingly being implemented, and CTD or eCTD submission is
required in most countries. Accurate preparation of the CTD is essential for
obtaining prompt approvals and ensuring successful market entry globally.
Q) Module of CTD
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Module 1: Regional and Administrative Information
This module includes region-specific administrative
documents, such as application forms, legal documents (e.g., GMP certificates,
licenses), and labeling information tailored to the requirements of the target
regulatory authority.
Module 2: Overall Summary
Module 2 provides a comprehensive summary of Modules
3, 4, and 5. It includes the Quality Overall Summary (QOS), Non-clinical
Overview, and Clinical Overview. This section offers an abstract of the
documents provided in the entire submission, highlighting key points from each
module.
Module 3: Quality
This module contains documents related to chemistry,
manufacturing, and control (CMC) of both the drug substance and drug product.
It provides detailed information on the formulation, manufacturing process,
quality control, and stability data required for regulatory review.
Module 4: Safety
Module 4 includes non-clinical safety data, such as
pharmacological, pharmacokinetic, and toxicological studies. It also includes
stability data relevant to the safety of the drug substance and drug product.
Module 5: Efficacy
This module contains clinical study reports and a
critical assessment of clinical data. The applicant provides an in-depth
analysis of the clinical trial results, including efficacy, safety, and
risk-benefit considerations, to support the drug's approval.
This module includes region-specific administrative
documents, such as application forms, legal documents (e.g., GMP certificates,
licenses), and labeling information tailored to the requirements of the target
regulatory authority.
Module 2: Overall Summary
Module 2 provides a comprehensive summary of Modules 3, 4, and 5. It includes the Quality Overall Summary (QOS), Non-clinical Overview, and Clinical Overview. This section offers an abstract of the documents provided in the entire submission, highlighting key points from each module.
Module 3: Quality
This module contains documents related to chemistry, manufacturing, and control (CMC) of both the drug substance and drug product. It provides detailed information on the formulation, manufacturing process, quality control, and stability data required for regulatory review.
Module 4: Safety
Module 4 includes non-clinical safety data, such as pharmacological, pharmacokinetic, and toxicological studies. It also includes stability data relevant to the safety of the drug substance and drug product.
Module 5: Efficacy
This module contains clinical study reports and a critical assessment of clinical data. The applicant provides an in-depth analysis of the clinical trial results, including efficacy, safety, and risk-benefit considerations, to support the drug's approval.
Remember that different regulations apply in each country.
Contact us today to discover how our drug ingredient and label compliance can benefit your business.
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cosmetic regulations.
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