globo_gris_transparente

Tag: Import Testing

Los inspectores de la FDA en instalaciones extranjeras enfrentan desafíos en la supervisión de la calidad.
Society

Reimagining Quality Control in Prescription Drug Manufacturing

The FDA faces challenges in overseeing the quality of drugs, especially in foreign facilities. Improvements such as unannounced inspections, increased frequency of inspections, and alternative monitoring tools are proposed. It is suggested that importers designate a qualified individual in the U.S. to certify compliance with Good Manufacturing Practices (GMP) to strengthen the U.S. drug quality control system.

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