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 ...

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 ...

The US Food and Drug Administration (FDA) on Wednesday finalized its questions and answers guidance on complying with data integrity requirements under current good ...

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 ...

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 ...

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 ...

Portfolio of CTGrade cytokines and growth factors contain no animal- or human-derived materials Expansion of CTGrade portfolio resulting from the acquisition by FUJIFILM Irvine Scientific earlier this ...

WILMINGTON, N.C.--Pharmaceutical Product Development, LLC (PPD) is expanding its cGMP cell-based assay laboratory in Middleton, Wis., to meet the growing needs of clients seeking to validate bioassays ...