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Pharmaceutical manufacturing in Europe is at risk of critical medicine shortages, states the European Federation of Pharmaceutical Industries and Associations (EFPIA), if the widest chemical substance restriction, concerning Per- and Polyfluoroalkyl Substances (PFAS), is put in place.
The International Society of Pharmaceutical Engineering’s GAMP® 5 guidelines steer validation practices for pharma companies to meet computerized system expectations. Members of the GAMP steering committees, Lorrie Schuessler, Charlie Wakeham and Stephen Ferrell, share the some of the key changes in the second edition update and how these should be…
The International Society for Pharmaceutical Engineering (ISPE) has published the Good Practice Guide: Continuous Manufacturing of Oral Solid Dosage Forms, in a bid to increase uptake.
Twenty five years ago, the European Community took a major step toward political and economic union by adopting the Treaty of Maastricht. The Treaty created the European Union (EU), paving the way for closer economic ties within the Union through the free movement of goods between member states. This opening…
European Pharmaceutical Review has brought you the most up-to-date and relevant pharmaceutical science for the past 21 years. This anniversary supplement brings you a selection of topical views from across the industry, reviewing progress over that time, as well as looking to the future.
New ISPE guidance provides a scientific, risk-based approach for managing cross-contamination risk within shared facilities ...
This article discusses ISPE’s Product Quality Lifecycle Implementation (PQLI) initiative, which is to provide practical guidance for implementation of ICH Q8, Q9 and Q10. It represents the author’s individual opinion. It should be noted that PQLI is an evolving work area and so will continue to develop beyond the position…
