Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

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

USP Launches Whatsapp Channel

USP has launched a WhatsApp channel. Through the channel, followers will receive updates in USP

OAI Classification for Sun Pharma Halol

In September 2025, the USFDA classified Sun Pharmaceutical Industries Ltd.’s Halol facility as OAI (Official

India to Allow Manufacture of New Drugs

Government of India is amending the New Drugs and Clinical Trials (NDCT) Rules 2019 permitting

Japan Generics to Have Zero Percent Tari

Under a new trade deal, the U.S. government is bringing down tariffs on generic drugs

Amneal Warning Letter Cites Fibers in PP

The USFDA issued a Warning letter to Amneal Pharmaceuticals following critical deviations observed during an

India Makes Disclosure of Excipients on

Government of India has published the Gazette notification to make disclosure of Qualitative details of

FDA 483 to Catalent Indiana Flags Inadeq

Novo Nordisk owned Catalent Indiana sterile products formulation facility was inspected by USFDA in June

FDA Approves Insmed’s New Oral Lung Di

USFDA has approved Insmed’s Brinsupri (Brensocatib) for Bronchiectasis, a chronic drug disease. The medicinal product

MHRA on FDA Warning Letters

In a blog posted on 8 August 2025, MHRA’s Chris Jones (IAG Chair) and Himal Makwana

EC Issues Annexure 22 – Draft Guid

The European Commission (EC) has published a draft guidance – Annexure 22 – Artificial Intelligence