• ICH Background/Working Groups
• ICH 5-Step Process
• CTD Modules

• S.1 General Information: Nomenclature, Structure, General Properties
• S.2 Manufacture
  • Manufacturers 
  • Description of Manufacturing Process and Process Controls
    • Flow diagram
    • Process Narrative 
    • Process Controls
  • Control of Materials
    • Starting Materials
    • Reagents, Solvents, Auxiliary Materials
  • Control of Critical Steps and Intermediates
  • Manufacturing Process Development
• S.3 Characterization
  • Elucidation of Structure
  • Other Characteristics
    • Physicochemical properties
    • Solid State Forms
  • Impurities
    • Types (organic, inorganic, residual solvents)
    • Classification (specified/unspecified, identified/unidentified)
    • Reporting, Identification and Qualification Thresholds
    • Acceptance Criteria
    • Qualification
• S.4 Control of the Drug Substance
  • Specifications
  • Analytical Procedures
  • Validation of Analytical Procedures
  • Batch Analyses
  • Justification for Specifications
• S.5 Reference Standards
• S.6 Container Closure System
• S.7 Stability
  • Stability Protocol and Data Evaluation
  • Forced Degradation/Stress Testing
  • Photostability
  • Stability Summary and Conclusion
  • Post-approval Stability Protocol and Commitment
  • Stability Data

Drug Master Files

• What are they
• Types of DMFs
• How are they used?
• When are they used?
• Information in a DMF vs. NDA

• P.1 Description and Composition
• P.2 Pharmaceutical Development
  • Drug Substance
  • Excipients
  • Formulation Development
  • Manufacturing Process Development
  • Container Closure Suitability
• P.3 Manufacture
  • Manufacturer
  • Batch Formula
  • Description of Manufacturing Process and Process Controls
  • Control of Critical Steps and Intermediates
• P.4 Control of Excipients
• P.5 Control of the Drug Product
  • Specifications (release, stability, in-house)
  • Analytical Procedures
  • Validation of Analytical Procedures
  • Batch Analyses
  • Justification of Specifications
• P.6 Reference Standards
• P.7 Container Closure Systems
  • Primary, Secondary, Functional and Non-Functional Secondary Packaging
• P.8 Stability
  • Stability Protocol and Data Evaluation
  • Forced Degradation/Stress Testing
  • Photostability
  • Stability Summary and Conclusion
  • Post-approval Stability Protocol and Commitment
  • Stability Data

Regional Information

• Executed Batch Records
• Comparability Protocols
• Method Validation Package

• Module 2 of CTD

FDA Interactions

• Meetings and Preparations
• Questions

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