PharmOut, a professional consultancy specializing in GMP compliance, has created an online database of GMP guidelines. This database, available at http://gmp.pharmout ...

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 ...

Reston, Va.—The U.S. Food and Drug Administration (FDA) announced publication of a final regulation on current good manufacturing practices (cGMPs) for the production of positron emission tomography ...

GMP release and stability testing are indispensable elements of the pharmaceutical sector’s quality assurance strategy. These testing protocols not only ensure that pharmaceutical products are safe ...

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 ...