Industries: Pharma / Biotech

Preparing the CMC Section for MAAs-IMPDs

Course Director: Laura Millichamp

Course Fee: $2150.00 Regular Registration / $1950.00 Early Bird (30 Days in Advance)

  Accreditation: ***RAPS Approved Course***

Course Description - Course runs 9:00 to 5:00 both days (Breakfast & Lunch Included)

This course includes an overview of the relevant guidelines and the organization of the CTD, detailed information and discussions related to each element required in the drug substance and drug product sections of MAAs. The course will emphasize the requirements related to drug substance starting materials, drug substance and drug product specifications, impurities, stability, manufacturing and pharmaceutical development. It will also discuss the use of Drug Master Files (DMF), Certificates of Suitability (CEPs) and preparation of the CTD Quality Overall Summary (Module 2).

Who Should Attend

This course is designed for personnel involved in preparing the chemistry, manufacturing and controls (CMC) section of an MAA, and for personnel who are not involved in CMC document preparation but want an overall understanding of what is involved for both the drug substance and drug product. Note that the course covers the requirements for synthetic, small molecules and does not address biologics.


9:00 – 10:00 Relevant Guidelines

  • EU Directives and Guidelines

10:00 – 4:30 Requirements for the Drug Substance (Module 3 of CTD)

  • General Information: Nomenclature, Structure, General Properties
  • Manufacture
    • Manufacturers
    • Description of Manufacturing Process and Process Controls
      • Flow Diagram, Process Narrative and Controls
      • Control of Materials
      • Starting Materials, Reagents, Solvents
    • Control of Critical Steps and Intermediates
    • Manufacturing Process Development
  • Characterization
    • Elucidation of Structure
      • Other Characteristics, Physicochemical properties, Solid State Forms
    • Impurities
      • Types (organic, inorganic, residual solvents)
      • Specified vs. unspecified
      • Specifications
      • Reporting, Identification and Qualification Thresholds
      • Qualification
      • Genotoxic Impurities
  • Control of the Drug Substance
    • Specifications
    • Analytical Procedures
    • Validation of Analytical Procedures
    • Batch Analyses
    • Justification for Specifications
  • Reference Standards and materials
  • Container Closure System
  • Stability
    • Stability summary and conclusions
    • Post-approval Stability Protocol and Commitment
    • Stability Data

4:30 – 5:00 Drug Master Files (DMFs) and CEPs

  • What is a DMF
  • What is a CEP
  • What are the key differences and how is each used


9:00 –2:30 Requirements for the Drug Product (Module 3 of CTD)

  • Description and Composition
  • Pharmaceutical Development
    • Components of the Drug Product
    • Formulation Development
    • Manufacturing Process Development
    • Container Closure Development
    • Microbiological Attributes
    • Compatibility
  • Manufacture
    • Manufacturer
    • Description of Manufacturing Process and Process Controls
    • Control of Critical Steps and Intermediates
    • Process validation
  • Control of Excipients
  • Control of the Drug Product
    • Specifications
    • Analytical Procedures
    • Validation of Analytical Procedures
    • Batch Analyses
    • Characterization of Impurities
    • Justification of Specifications
  • Reference Standards
  • Container Closure Systems
  • Stability
    • Stability Summary and Conclusion
    • Post-approval Stability Protocol and Commitments
    • Stability Data

2:30 – 3:00 Regional Information

3:00 – 3:30 Quality Overall Summary (Module 2 of CTD)

3:00 – 3:30 Quality Overall Summary (Module 2 of CTD)

  • How to respond to Regulatory Authority requests for information

Learning Objectives

This course will provide participants with a thorough understanding of the requirements for each CMC/Quality section of the Common Technical Document (CTD), the format to be used for MAAs, including preparation of the Quality Overall Summary (Module 2). It will also present techniques for making the CMC submission easy to review, and discuss how to address requests for clarification.