PPT Slide

4. Routine Extractables Testing

Is quantitative testing of extractables appropriate for control of composition of all components?

The Leachables and Extractables Team, in collaboration with Supplier QC Team, will propose a control strategy combining appropriate scientific practices, cGMP controls and supplier qualification systems for ensuring the relevant performance and safety characteristics of critical components

TEAM’S TOPICS FOR STUDY

CMC Leachables and Extractables Technical Team

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