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2022 ISPE Annual Meeting & Expo

SES213c - Addressing Divergent Global QOS Requirements

Nov 1, 2022 4:00pm ‐ Nov 1, 2022 5:30pm


ICH M4Q(R1) provides a harmonized structure and format for presenting detailed CMC information the Common Technical Document (CTD). Although several countries have implemented the CTD format, many have adopted quality documentation expectations that exceed ICH guidance and in effect create divergent expectations for CMC content that presents a considerable barrier to harmonized global applications and approvals. This presentation will offer a proposal for a more comprehensive QOS document which leverages alternative tools outlined in ICH Q12 to potentially fulfill the requirements of regulatory authorities world-wide. A single global QOS format would enable expeditious and simultaneous submission of applications globally to improve the efficiency and economy of regulatory review and risk assessment of an application while providing a mechanism for industry to convey a holistic view of their control strategy and present established conditions which facilitate life cycle management and continuous supply.


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