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 ...
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FDA 510(K) Approved Facilities: Increasing GMP Inspections And Compliance RequirementsAchieving 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 ...
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 ...
Adragos Pharma, a global pharmaceutical contract development and manufacturing organization (CDMO) headquartered in Munich, ...
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 ...
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