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47882

Parallel Session 6 - ICH Q14 and Q2(R2) Concepts and Enhanced Approaches to the Analytical Method Lifecycle

Date
January 25, 2023
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With the endorsement from ICH Management Committee in 2018 to introduce a new quality guideline for Analytical Development (ICH Q14) and a complementary revision of ICH Q2(R1) for Validation of Analytical Procedures, product owners will gain further guidance on enhanced approaches to analytical method development and validation. ICH Q14 will provide tools to harmonize scientific approaches for analytical method development. Currently, details of analytical development are not presented as part CTD Module 3 or other formal communications with regulatory agencies, unless to provide justifications for change category classification for post-approval changes of analytical procedures. Revisions to ICH Q2(R1) will provide a link to the Q14 principles and clarity in the existing guidelines for method validation and transfer as well as additional guidance for emerging analytical control techniques such as spectroscopic assays.
The development of a suitable analytical procedure requires understanding of product and processes, defining quality attributes of the active substance and selection of the right technology to deliver robust performance within an operating range. The combination of the proposed guidance may facilitate the selection and application of enhanced development approaches that could reduce the risk incurred by post-approval changes to analytical procedures discussed in ICHQ12: Pharmaceutical Product Lifecycle Management.
This session will focus on the concepts outlined in the new draft guidance ICH Q14 and revised ICHQ2 and enhanced approaches to the analytical method lifecycle using case studies and examples. Topics in scope include principles of the new guidance, accelerated development and post approval strategies, platform methods and leveraging prior knowledge.