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
Formati files ammessi: PDF editabile o p7m. Scansioni a 200 dpi, anche in bianco e nero, per ottimizzare...
15
Mag
US FDA’s New AI-Informed Inspection Pilot and What It Means for Industry
We have written on this blog about FDA’s modernization agenda from several angles lately—from...
15
Mag
EU Regulators discuss new pharma legislation, AI, and more
A panel of European regulators answered questions during a town panel discussion at RAPS Euro Convergence...
15
Mag
US FDA official details top observations from QMSR inspections
The top observations identified in Form 483 reports from inspections conducted under the recently implemented...
le ultime news
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27 Feb
US FDA Announces the 2026 QMM Prototype Assessment Protocol Evaluation Program
27 Feb
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24 Feb
Industry clamors for clearer guidance on transition to ICH M4Q(R2)