08.10.24 -- Pharmaceutical Online Best Of July

AI has made its way into the biopharma laboratory, and ChatGPT-4 is the most popular. Do you know the capabilities that this tech can deliver?

Ready or not, when the FDA inspector arrives, the test has already started. New final guidance makes clear what the agency considers an attempt to stonewall.

Your company likely uses risk matrices and FMEA for analyzing risks. This article describes an alternative approach for conducting a system failure mode and effects analysis.

CAPA processes, though often seen as regulatory burdens, offer significant business benefits. Implementing them requires a cultural shift and methodical approach for lasting improvement.

Acquire a thorough understanding of environmental monitoring, covering the fundamentals of particle counting and cleanroom designs, regulatory expectations regarding market release, and more.

What does Annex 21 entail? What makes the process of meeting the requirements so complex and time-consuming? And has Annex 21 inadvertently created additional barriers to supply?