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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
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
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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