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Lifecycle Management of Analytical Procedures: Method Development, Procedure Performance Qualification, and Procedure Performance Validation | IVT

In this Stimuli article, the USP Validation and Verification Expert Panel discusses how the modern concept of a lifecycle model, which is based on process validation and described in ICH guidelines Q8, Q9, and Q10, can be applied to analytical procedures. The Expert Panel proposes that the traditional approaches to validation, transfer, and verification should be integrated into the analytical procedure lifecycle process rather than being viewed as separate entities.

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