This Auditing for GMP course is specifically designed to address the challenges of GMP auditing for the pharmaceutical industry and present the basic competencies required to effe ...

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 ...

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

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 ...