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Quality risk assessment and management for the application of the single-use systems

  • At: 2017 FIP Congress in Stockholm (Sweden)
  • Type: Presentation
  • By: HIROSE, Akihiko (National Institute of health sciences, Division of Risk Assessment, Tokyo, Japan)
  • Co-author(s): Akihiko Hirose: Division of Risk Assessment, National Institute of health sciences, Tokyo, Japan
    Tomoko Kawamura: Division of Risk Assessment, National Institute of health sciences, Tokyo, Japan
    Mariko Matsumoto: Division of Risk Assessment, National Institute of health sciences, Tokyo, Japan
    Takashi Yamada: Division of Risk Assessment, National Institute of health sciences, Tokyo, Japan
    Akiko Ishii-Watabe: Division of Biological Chemistry and Biologicals, National Institute of health sciences, Tokyo, Japan
  • Abstract:

    Not only leachables from the packages used for biologics, but also leachables from the apparatus used in the Single-Use Systems (SUS) may especially affect quality of the biological components and harm patient health. Therefore, developing of the comprehensive risk management method for all chemical impurities that might be introduced during the

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Last update 4 October 2019

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