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Preparing the Quality Module of the CTD

5-week online course | 2 hours per week

16 September - 28 October 2019

Online Academy

Module 1:

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CMC in the Drug Development Programme
  • Timelines for product development.
  • Considerations for CMC Data Requirements at different stages of drug development.
  • Other considerations impacting CMC and Drug Development.

Module 2:

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Module 3 & Quality Overall Summary
  • Module 3 structure & Quality overall summary (QOS).
  • Purpose and Content of Module 3 and QOS
  • QOS Strategy
  • Future Perspective

Module 3:

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Preparing the Drug Substance section of the application
  • Analysing the needs for the section
  • How to submit information – Drug Master Files, Certificates of Suitability, other methods
  • Detailed information requirements for the section

Module 4:

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Essential information from API suppliers
  • Identify essential data requirement
  • Understand the essential requirements from API suppliers / manufacturing section
  • Impact on finished products

Module 5:

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Meeting manufacturing and inspection requirements
  • Regulatory compliance and manufacturing issues in relation to the application
  • Clarifying manufacturing licence criteria
  • Preparing for pre-approval inspection
  • Examining GMP Module 3 (CTD)

Module 6:

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Writing the section on manufacture of the drug product and process validation
  • Examining the content of the section: How much information to provide
  • Defining the difference between process development and validation
  • Post-approval commitments
  • Writing the sections on excipients
  • Examining the content of the section

Module 7:

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Writing the sections on control of the finished product
  • Examining the content of the section
  • Control of the drug product

Module 8:

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Module 7 Specifications
  • Identify and understand the writing of specifications Dossier Requirements.
  • Adjusting specifications during development.
  • Justification of specifications.

Module 9:

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Stability Section
  • Examine the content of the section
  • Evaluation of stability data and the impact on shelf-life
  • QbD and Stability

Module 10:

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Pharmaceutical Packaging
  • Regulatory requirements for pharmaceutical packaging.
  • How to reflect requirements in the dossier.
  • Quality and suitability of packaging.
  • Packaging specifications.