This article highlights the thoughts shared by the FDA speakers, including the importance of a quality infrastructure, sustainable compliance, data integrity, and more.
It is sometimes astonishing how often pharmas and biotechs commit similar or even the same GMP mistakes — in (almost) always the same places. Here are two of the most common pitfalls to avoid: inadequate handling of deviations and inadequate handling of changes.
You may have questions or knowledge gaps regarding technology transfers. To help your understanding, we’ve compiled a beginner’s guide to technology transfer fundamentals.
Review the scope and testing procedures required by General chapter USP <382> Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systems.
AKTA go is a small and compact liquid chromatography system that allows researchers to perform routine protein purification with ease while allowing for efficient use of bench and cold cabinet space.
This e-book demonstrates process intensification approaches that enable the development and production of high-quality, niche-segment drugs in a more efficient and cost-effective way.
Explore the three phases of sterile injectable project tech transfer, including how to bridge information gaps and facilitate successful regulatory filing at this fundamental stage of drug development.
