Pharmaceutical manufacturing is at a turning point. For decades, large-scale centralized facilities have been the backbone of medicine production, but today’s healthcare landscape demands something different: flexibility and personalization. Patients need therapies that are accessible anywhere, tailored to individual needs, and produced with resiliency against shortages. Emerging models like...
At the 2025 ISPE China Conference in Shanghai, China in May 2025, Marcus Ray, Medical Products Supervisor at the US Food and Drug Administration’s (US FDA) China Office, delivered a comprehensive update on the agency’s regulatory and inspectional activities. His presentation, titled “FDA Regulatory and Inspection Updates,” offered a detailed look at the FDA’s evolving global strategy, with a...
On the closing morning of the 2025 ISPE Europe Annual Conference, Ian Jackson, an expert GMP inspector with the Medicines and Healthcare products Regulatory Agency (MHRA), presented MHRA’s Policy for the Future and Globalized Industry.
The presentation by Ian Deveau, PhD, from the US Food and Drug Administration (US FDA) Office of Compounding Quality and Compliance at the 2024 ISPE Annual Meeting & Expo on 15 October 2024 provided an in-depth look at the US FDA’s perspective on drug compounding, its regulatory framework, and the significant events that have shaped current practices. Here is a summary of the key points...
This blog summarizes a presentation by Rick Friedman, Deputy Director of the US FDA Office of Manufacturing Quality, on 17 April 2024 at the 2024 ISPE Europe Annual Conference in Lisbon, Portugal. The...
Carla J. Lundi, US Food and Drug Administration (FDA) Senior Consumer Safety Officer, Division of Quality Intelligence II, FDA, presented the regulatory keynote at the 2024 ISPE Facilities of the Future...
