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

so sites must reevaluate their quality and safety credentials and maintain a state of good manufacturing practice (GMP) readiness. Throughout the pandemic, the lack of FDA inspections has created ...

Achieving FDA CFR 820 audit success requires a “systematic and proactive approach” to compliance: 1. Management commitment and resource allocation are vital for successful GMP implementation ...

Mary Kay Bates, senior global cell culture scientist at Thermo Fisher Scientific, explores best practices for implementing ...

Achieving FDA audit success requires a “systematic and proactive approach” to compliance: 1. Management commitment and resource allocation are critical to the success of any GMP implementation ...

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 recently published a Federal Register notice announcing a public listening session on good manufacturing practices (GMPs) for cosmetic products under the Modernization of Cosmetics Regulation ...

While the ATA3219 drug product is manufactured at a separate, fully compliant GMP-certified facility, the compliance issues at the same third-party facility referenced in the CRL affect the ...

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

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 ...