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ICH Q2(R2) (Validation of Analytical Procedures) and ICH Q14 . . . - CASSS Q14 –Thoughts on implementation • Some concepts in Q14 already implementable (without new guidance) • Align with Q12 which has been adopted by all ICH regulatory members • Exploit existing lifecycle concepts for Analytical Procedures • Q12 will take time to implement in some regions (inc EU)
Proposed ICH q14 examples for ATP and change management - CASSS An aspiration of Q14 is to provide avenues for enabling post-approval analytical procedure changes through some combination of demonstrated enhanced method understanding and adherence to well-defined EC’s, including ATP
Understanding ICH Guideline Q14 by Rajesh Sadhwani - Prezi ICH Q14 provides guidelines that enhance method validation throughout these stages, focusing on a quality-by-design (QBD) framework Real-world examples illustrate that companies adopting Q14 alongside QBD principles have achieved faster market approval and improved product quality
Q14: Analytical Procedure Development Q2 (R2): Validation of Analytical . . . ICH Q14 describes the scientific principles for development, change management and submission requirement of analytical procedures for the minimal and enhanced approach ICH Q2(R2) provides guidance for establishing, submitting and maintaining evidence that an analytical procedure is fit for purpose (assuring drug quality)
ICH Q2(R2) Q14 Analytical Procedure Validation and Development Objectives ICH Q14 • Harmonise the scientific approaches to analytical procedure development, and provide the principles relating to the dossier description • Improve regulatory communication between industry and regulators and facilitate more efficient, sound scientific and risk-based approval as well as post-approval change
Overview of ICH Q2(R2) Q14: Development and Validation of . . . - CASSS ICHQ14: Analytical Procedure Development Chapter 2 2: Minimal versus Enhanced Approaches to Analytical Procedure Development • Identifying attributes need to be tested • Selecting appropriate technology and related instruments • Conducting appropriate development studies • Defining analytical procedure description Minimal approach •
The Future is Now: ICH Q14: Analytical Procedure Development . . . - CASSS Q14 is New (sort of) •Applying principles described in ICH Q14 can improve regulatory communication between industry and regulators and facilitate more efficient, sound scientific and risk-based approval as well as post-approval change management of analytical procedures •ICH Q14 establishes harmonized scientific and