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II. 7 Quality risk management as part of…. Laboratory control and stability testing. Industry. Competent Authorities. II.7: QRM as part of laboratory control and stability testing. Out of specification results

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II. 7 Quality risk management as part of…

Laboratory control and stability testing

Industry

Competent Authorities


II.7: QRM as part of laboratory control and stability testing

  • Out of specification results

    • To identify potential root causes and corrective actions during the investigation

  • Retest / expiration date setting

    • To evaluate adequacy of storage and testingof intermediates, excipients and starting materials

      • Challenge results of use tests

      • Stress tests

ICH Q9


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