【讨论】Analytical Methods - USP's Future Expectations

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The PharmacopoeialForum 39(5) contains an interesting article from the USP Validation andVerification experts group about USP's future requirements on the developmentand validation of analytical methods.
The article is entitled "Lifecycle Management of Analytical Procedures:Method Development, Procedure Performance Qualification, and ProcedurePerformance Verification".
In this article, the USP experts group discusses how the modern concept of alifecycle model (according to the ICH guidelines Q8, Q9, and Q10) can betransferred to analytical procedures. The experts group suggests that thetraditional approach to validation, transfer and verification should beintegrated into the new "lifecycle process" for the analyticalprocedure.
Concretely, they propose that the requirements for the measurement of criticalquality attributes should be established in the "Analytical TargetProfile".
In alignment with the process validation approach, three stages are proposed:
Procedure Design (development and understanding)
Procedure Performance Qualification
Continued Procedure Performance Qualification
The article alsodescribes possible approaches for changes and the related activities. At theend of the article, a summary table presents the new "Lifecycle Approach"against the current approach and lists all the advantages of the new approach.