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    Genmedix Profile

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    amin138ir
    This document outlines the necessary sections for a Drug Master File, including general information about the drug substance's nomenclature, structure, and properties. It also covers the manufacturing process and controls, characterization of the substance, specifications for quality control, reference standards, container closure system, and stability studies and data. The document provides a table of contents for stability testing and ensuring quality of the drug substance.

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    Attribution Non-Commercial (BY-NC)
    Download as PDF, TXT or read online from Scribd

    Genmedix Profile

    Uploaded by

    amin138ir
    128 views1 page
    This document outlines the necessary sections for a Drug Master File, including general information about the drug substance's nomenclature, structure, and properties. It also covers the manufacturing process and controls, characterization of the substance, specifications for quality control, reference standards, container closure system, and stability studies and data. The document provides a table of contents for stability testing and ensuring quality of the drug substance.

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    Genmedix company profile manufacturer of biotechnology products

    Original Title

    Genmedix profile

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    © Attribution Non-Commercial (BY-NC)

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    This document outlines the necessary sections for a Drug Master File, including general information about the drug substance's nomenclature, structure, and properties. It also covers the manufacturing process and controls, characterization of the substance, specifications for quality control, reference standards, container closure system, and stability studies and data. The document provides a table of contents for stability testing and ensuring quality of the drug substance.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    128 views1 page

    Genmedix Profile

    Uploaded by

    amin138ir
    This document outlines the necessary sections for a Drug Master File, including general information about the drug substance's nomenclature, structure, and properties. It also covers the manufacturing process and controls, characterization of the substance, specifications for quality control, reference standards, container closure system, and stability studies and data. The document provides a table of contents for stability testing and ensuring quality of the drug substance.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 1

    Drug Master File Applicant`s part

    Table of Content (necessary items)


    3.2.S.1 General Information
    3.2.S.1.1 Nomenclature
    3.2.S.1.2 Structure
    3.2.S.1.3 General Properties
    3.2.S.2 Manufacture
    3.2.S.2.1 Manufacturer
    3.2.S.2.2 Description of Manufacturing and Process Controls
    3.2.S.2.3 Control of Materials
    3.2.S.2.4 Controls of Critical Steps and Intermediates
    3.2.S.2.5 Process Validation and/or Evaluation
    3.2.S.2.6 Process Development
    3.2.S.3 Characterisation
    3.2.S.3.1 Elucidation of Structure and other Characteristics
    3.2.S.3.2 Impurities
    3.2.S.4 Control of Drug Substance
    3.2.S.4.1 Specification
    3.2.S.4.2 Analytical procedures
    3.2.S.4.3 Validation of Analytical Procedures
    3.2.S.4.4 Batch Analyses
    3.2.S.4.5 Justification of Specification
    3.2.S.5 Reference standards or Materials
    3.2.S.6 Container Closure System
    3.2.S.6.1 Description of Container Closure System
    3.2.S.6.2 Material of Construction of each Primary Packaging Component and Their
    Specifications
    3.2.S.6.3 Secondary Packaging Material
    3.2.S.6.4 Overall- Suitability of Materials Used
    3.2.S.7 Stability
    3.2.S.7.1 Stability Summary and Conclusions
    3.2.S.7.2 Post-approval Stability Protocol and Stability Commitment
    3.2.S.7.3 Stability Data

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