Will EMA Plans change the Landscape of GMP?

EMA has published a strategic reflection paper "EMA Regulatory Science to 2025". As a consequence, the regulatory landscape, including GMP requirements and standards, needs to be adapted.


Process Validation: The Impact of Equipment Change

In a previous News you could already read about the cleaning issues at a US-American pharmaceutical company. Now, the Warning Letter issued provides much more information - also with regard to process validation.


New VDI Guidelines for Clean Room Technology

The Association of German Engineers (VDI ="Verein Deutscher Ingenieure") has recently released two new draft guidelines from the area of clean room technology: one regarding central air handling systems, and the other one regarding air filter systems.


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