Discussion forum for Pharma Quality events, Regulatory Actions

Warning letters, 483s, Recalls, Import Alerts, Audit observations

Nitrosamines: USFDA issues guidance on R

USFDA: Recommended Acceptable Intake Limits for Nitrosamine Drug Substance[1]Related Impurities (NDSRIs) – Guidance for Industry

Qvents
August 9, 2023

EMA, the European Commission (EC) and th

EMA, the European Commission (EC) and the Heads of Medicines Agencies (HMA) are phasing out

Qvents
July 19, 2023