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

Nitrosamine Impurities in Pharmaceutical

Authored by: Venkiteswaran.T.K Nitrosamine impurities in pharmaceutical products are a significant concern due to their

Qvents
June 28, 2025

Supply Chain Traceability of Medicinal P

As per EUGMP requirements, EudraLex, Annex 16: Certification by a Qualified Person and Batch Release,

Qvents
May 31, 2025

Continuous Process Verification (CPV) an

Author: Venkiteswaran.T.K The USFDA’s 2011 guidance on process validation advocates a life cycle approach and

Qvents
May 16, 2025

Excipient Risk Assessment: Approach, Tem

According to the EU GMP guidance—“Guidance for Risk Assessment for Ascertaining the Appropriate Good Manufacturing

Qvents
April 24, 2025