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2022 ISPE Annual Meeting & Expo

SES03a - Industry Perspective: Considerations for Analytical Procedure Development, Validation, and Lifecycle Management in ICH Q2(R2) and Q14

Nov 1, 2022 10:45am ‐ Nov 1, 2022 12:15pm


This presentation will provide an overview of the current status of the analytical procedure development, validation, and lifecycle management principles in ICH Q2(R2) and Q14. The new revision of ICH Q2(R2) will continue to provide a general framework for the principles of analytical procedure validation and has been modernized to include newer technologies (e.g., for biological products or multivariate analytical procedures). ICH Q14 is the first ICH guideline that describes analytical procedure development and complements existing ICH guidelines for drug substance and drug product development. This talk will explain the use of the enhanced approach versus the minimal (traditional) approach and describe risk and change management principles in analytical procedure lifecycle management using the regulatory tools in ICH Q12 such as established conditions. A discussion of the application of development principles in ICH Q14 such as the Analytical Target Profile (ATP), how the guideline can facilitate analytical innovation and continual improvement, and practical examples will also be provided.


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