Cover: Emerging Leaders has grown from an initiative for interactions among early-career professionals and entering ISPE into much more: a training ground, a networking organization, and a new foundation for the future of ISPE and the industry. This article looks at the history of the group, its purpose, current and future initiatives, and a name change that better reflects the path of its members.
Feature: This article shares data that highlight instances where well-established ICH regulatory members diverge from International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) quality guidance in their evaluation of the same scientific data in chemistry, manufacturing, and controls (CMC) regulatory documents submitted by industry. The data illustrate instances when regulatory divergence led to modifications to control strategies that in turn led to multiple regional and local control strategy variants globally
Feature: With the rise of new technologies and predictive analytics capable of handling the huge amounts of data within and across existing information systems, Industry 4.0 has been thriving in many sectors, such as industrial automation, financial technology, retail, and semiconductors. But the health sector in general, and the pharmaceutical industry in particular, has been considered a conservative area, in which innovation has not been adopted as quickly as in other sectors. This article explores how the pharma industry’s adoption of innovation is measured and how the regulated nature of the industry may influence its pace of innovation.
Technical: This article presents the results of applying artificial intelligence (AI) such as machine learning algorithms to identifying and predicting anomalies for corrective maintenance in a water for injection (WFI) processing plant. The aim is to avoid the yearly stoppage of the WFI plant for preventive maintenance activities, common in the industry, and use a more scientific approach for the time between stoppages, expected to be longer after the study and thus saving money and increasing productivity.