The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guideline on Registration of Pharmaceuticals for Human Use (M4) offers advantages in the consistent format of the registration dossier using the Common Technical Document (CTD). However, it does not deliver a comprehensive view of the overall manufacturing control strategy or a means of understanding and managing the quality of the product throughout its life cycle. As a result, several regulatory authorities that have implemented the CTD format have also insisted on supplementary quality summary documentation that exceeds ICH requirements, and, in effect, creates divergent expectations for chemistry, manufacturing, and controls (CMC) content. A single global quality overall summary (QOS) format could clearly convey a holistic view of a product’s control strategy and improve the efficiency and economy of the regulatory review of an application while providing a way for the applicant and reviewer to align on a product life-cycle management plan.
Best & Brightest Quality & Regulatory Content from the 2021 Conferences 78 Presentations Featuring 46+ Hours of Content No need to miss out on valuable knowledge-sharing! ISPE has gone through all of our conference...
A Vision for ICH Q12: Current Experience, Future Perspectives Cover: Management of global postapproval chemistry, manufacturing, and controls changes...
39 Presentations Featuring 18+ Hours of Content No need to miss out on valuable knowledge-sharing! ISPE has gone through all of our conference presentations from 2020, hand-selected the absolute best and brightest...
