Gellermann, Gerald, Mary Beth, Pelletier, Wang, Qinggang, Winfield, Carol, Castle, Bryan, Graul, Timothy and Cauchon, Nina (2025) Readiness for Implementation of ICH Q2(R2) and Q14: Results of a Cross-Industry Survey. ISPE Pharmaceutical.

Abstract

To assess industry readiness for the implementation of these guidelines and to understand challenges, opportunities, and overall preparedness of industry professionals, the ISPE-PQLI Analytical Method Strategy (ICH Q2(R2)/Q14) team conducted a comprehensive survey. The survey was conducted anonymously from April 18 to July 15, 2024, receiving 201 recorded responses. Fifty-seven of those responses provided answers to questions beyond the demographic information and are discussed below. These 57 responses are summarized along with optional free text responses provided by the respondents, and the findings and key takeaways from the survey are presented.

Item Type:	Article
Date Deposited:	10 Feb 2026 00:45
Last Modified:	10 Feb 2026 00:45
URI:	https://oak.novartis.com/id/eprint/57119