Table I

Management Responsibilities (ICH Q10)

  • Participate in the design, implementation, monitoring, and maintenance of the QS.

  • Demonstrate strong and visible support for the QS and ensure its implementation.

  • Ensure effective communication process exists to raise quality issues to the appropriate level.

  • Define roles and responsibilities and organizational interrelationships.

  • Conduct management reviews.

  • Advocate continual improvement.

  • Commit appropriate resources.