Excipient Risk Assessment: Approach, Tem
According to the EU GMP guidance—“Guidance for Risk Assessment for Ascertaining the Appropriate Good Manufacturing
Warning letters, 483s, Recalls, Import Alerts, Audit observations
According to the EU GMP guidance—“Guidance for Risk Assessment for Ascertaining the Appropriate Good Manufacturing
USFDA Warning letter to Dupont cites inadequate OOS investigations, Root cause and CAPA, Impact evaluation. The warning letter
IPEC Federation announced the availability of the “Questionnaire for Excipient Nitrosamines Risk Evaluation” (version 1,
USFDA issues Warning letter to DuPont Nutrition USA Inc., Newark, Delaware facility (FEI 3013947845) for