Module 9 2024

03/09/2024

Prior to Assay Validation I

• Development and optimization comprehensive

• Robustness studies (advised - ICH Q14)

• Characterization/Qualification Studies

Monitoring and trending

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• Setting acceptance criteria, can be preliminary

…………… not always a linear sequence

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Prior to Assay Validation II

Finalize method procedure

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Select validation sample(s)

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Write Validation Protocol

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GMP QA sign-off

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