FOYA Winners in the Supply Chain Category exemplify the novel application of process manufacturing techniques, innovative design concepts, new technologies, and unique solutions that exemplify the next generation of agile, flexible, efficient, and effective new and existing pharmaceutical and biotechnology facilities. This includes implementation of commercially available and custom developed...
Pharma 4.0™ is a new category for the Facility of the Year Awards (FOYA) program. Winners in the Pharma 4.0 category embody the Pharma 4.0 concept. This includes not only implementing at least one technological innovation, but also demonstrating the ability to change the company’s culture, processes, and people orienting them towards a 4.0 future. Significant contributions include application...
Effective and timely management of change throughout the product life cycle enables quality improvement and is critical to patient safety, supply reliability, and operational effectiveness and efficiency. The ISPE Advancing Pharmaceutical Quality (APQ) Guide: Change Management System provides a quality management framework for assessing and advancing change management (CM) system maturity...
ISPE has more than 17 global Communities of Practice (CoPs) where members can connect with each other. Professional Communities of Practices for
Released in November 2021, the ISPE Guide: Advanced Therapy Medicinal Products (ATMPs)–Autologous Cell Therapy focuses on manufacturing facility development and design for autologous cell therapies for...
