Quality & Compliance

The industry is under pressure to reduce the risks of nitrosamines in both in-development and on-market drug products.

EU-based associations voice concerns over joint clinical assessments and the lack of advice meetings.

A Pistoia Alliance survey looks at stakeholder concerns in AI regulations, and calls for more harmonization and collaboration.

The rocket-fueled dreams of a young engineer applied to the cleanroom industry.

Here’s a look at recent violations cited in FDA Warning Letters: fly pupae, cross contamination, trial dosing errors, and more.

The Alliance for RTU has been founded to accelerate and improve manufacturing quality, consistency, and regulatory efficiency.

What’s going on with nitrosamines? Naiffer Romero from the USP walks us through frequently asked questions.

How a new collaboration looks to improve analytical testing for mRNA products.

Counterfeit deterrents are not yet available in some regions. We speak with Advanco CEO Alf Goebel to find out why.

What does sustainability look like at Cytiva?