In an unprecedented time amid the global COVID-19 pandemic, an increasing number of pharmaceutical manufacturers and developers of active pharmaceutical ingredients are involved in the potentially ...

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...

As a background summary, CGMP represents the Current Good Manufacturing Practice regulations enforced by the US Food and Drug Administration (FDA). CGMP guidelines provide for systems that give ...

Sphere Fluidics, a company developing single cell analysis systems underpinned by its patented picodroplet technology, today announced updates to its flagship platform, Cyto-Mine ®, enabling it to be ...

This article outlines guidelines for the testing of high pressure gases utilized in cleanrooms according to the cleanliness limits stated in the FDA cGMP guidelines, the ISO 14644-1 cleanroom ...

Manufacturers are usually subjected to a diverse variety of regulations typically established by international and regional bodies. Failure to comply can result in the loss of authorization and ...

The FDA cited a skincare product manufacturer in a warning letter for significant violations of cGMP for finished drugs and APIs, along with several misbranding issues. The agency issued a warning ...