Quality & Compliance

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?

Following on from deaths attributed to contaminated medicines, here’s how the US Pharmacopeia is promoting testing for DEG and EG.

Introducing the British Standards Institution’s new environmental initiative to minimize antimicrobial resistance caused by manufacturing operations.

Data is power when it comes to batch-quality prediction and obtaining the coveted perfect profile.

It’s December – time for The Medicine Maker to welcome you to 2023’s most innovative new technologies in drug development and manufacturing