IPEC Excipient Regulatory Overview – The Impact of Composition and Excipient Variability on QbD and Drug Performance

David Schoneker, Colorcon, Pennsylvania, USA

  • Introduction to IPEC and how IPEC Guidelines have become the Global Excipient expectations in most regions
    • What is IPEC?
    • The Need for IPEC
    • Total Excipient Control
    • Existing IPEC Guidelines regarding Excipient Design, Safety, Excipient Mfg. Process Control and Distribution
  • Differences between Food Additives, Excipients and APIs
  • Diverse Sources
  • Manufacturing Realities
  • Differences in Appropriate GMPs
  • Major Components
  • Residual Solvents
  • Elemental Impurities
  • Genotoxic Impurities
  • Additives and Residual Processing Aids
  • Unknown Unknowns
  • Excipient Critical Material Attributes
  • Sampling Concepts for Design of Experiments
  • Use of the FDA’s Inactive Ingredient Database (IID) to determine a Precedence of Use
  • Current Status of the IID
  • New Concepts for Novel Excipient Safety Evaluation (Qualification)
  • Excipient Compositional Profile – IPEC Composition Guide
  • Impact of Excipient Variability of Physical and Chemical Properties on QbD, Drug Performance and Stability
  • Excipient Safety Evaluation

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