News dal mondo
27
Apr
US QMM: Participants scored well on commitment to quality, lower on advanced manufacturing
Pharmaceutical companies participating in the US Food and Drug Administration (FDA) Quality Maturity Pilot (QMM) program generally received high scores for their commitment to quality and employee engagement, but scored lower in areas related to advanced pharmaceutical quality and technical excellence. Eric Twum, a regulatory specialist for the Division of Quality II in the Office of Quality Surveillance (OQS) within the Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER), shared these insights on the QMM pilot at the Generic Drugs Forum held online and in White Oak, MD, on 22 April....[RAPS]
18
Giu
AIFA Sistema informatico Workflow Officine Materie Prime - Ulteriore Aggiornamento tecnico 18 maggio 2026
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We have written on this blog about FDA’s modernization agenda from several angles lately—from...
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The top observations identified in Form 483 reports from inspections conducted under the recently implemented...
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US QMM: Participants scored well on commitment to quality, lower on advanced manufacturing