Module 9 2021

24/03/2021

Questions ??

The Organisation for Professionals in Regulatory Affairs

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Bioassay Validation

• ICH Q2 R1 “Validation objective of an analytical procedure (AP) is to demonstrate that the AP is suitable for its intended purpose” • It is a formal exercise, agreed Protocol sets out how the assay will assessed

• Pre-defined acceptance criteria • Should be phase appropriate…

The Organisation for Professionals in Regulatory Affairs

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