1 / 2

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

azure
Télécharger la présentation

II. 7 Quality risk management as part of…

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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

More Related