Bryan O’Donnell, Head of Quality at Gaelic Laboratories, explains how to navigate GMP challenges to ensure your company ...

This article is authored by Ranjit Barshikar, CEO, QbD International, CGMP Consulting, United Nations Adviser.

The FDA's Good Manufacturing Practice (GMP) regulations provide a framework of essential requirements for the methods, facilities and controls used in manufacturing, processing and packaging of a drug ...

The FDA issued a warning letter to ProRx, a compounding facility in Exton, Penn., after an inspection raised serious concerns regarding the safety and compliance of its drug products. The facility, ...

FDA places a clinical hold on Atara's EBVALLO and ATA3219 programs due to GMP compliance issues at a third-party facility. Atara to pause new participant enrollment; CAR-T programs may suspend in ...

The U.S. Food and Drug Administration (FDA) announced on Tuesday a proposal to require most food products to display nutrition information on the front of the package. The front-of-package (FOP ...

Adragos Pharma, a global pharmaceutical contract development and manufacturing organization (CDMO) headquartered in Munich, ...