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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. Out of specification results

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II. 7 Quality risk management as part of…

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  1. II. 7 Quality risk management as part of… Laboratory control and stability testing Industry Competent Authorities

  2. 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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