Índice

  • 01

    COURSE INFORMATION

  • 02

    General Concepts of Impurities.

    • Definition, origin, and specification of organic impurities
  • 03

    General Regulation and Specifications

    • Regulation

    • ICH Q3A - Impurities in new drug substances

    • ICH Q3B - Impurities in new drug products

    • ICH M7 – Control of mutagenic impurities

    • EMA Reflection Paper on The Qualification of Non-Genotoxic Impurities

  • 04

    Toxicological Characterization of Impurities

    • Toxicological evaluation

    • Determination of Toxicological Limits

    • Risk analysis

  • 05

    Case Studies

    • Case 1: Impurity in finished product

    • Case 2: Impurity in the drug substance

    • Case 3: Impurity in finished product

    • Case 4: Impurity in the drug substance

  • 06

    EXAM

    • Exam