Warning letters, 483s, Recalls, Import Alerts, Audit observations
As per EUGMP requirements, EudraLex, Annex 16: Certification by a Qualified Person and Batch Release,
Author: Venkiteswaran.T.K The USFDA’s 2011 guidance on process validation advocates a life cycle approach and
According to the EU GMP guidance—“Guidance for Risk Assessment for Ascertaining the Appropriate Good Manufacturing
Authored by: Srinivas Churya This Quality Insight post presents a concise approach for selection and
Authored by: Venkiteswaran.T.K Nitrosamine impurities in pharmaceutical products are a significant concern due to their
The FDA inspected Colgate-Palmolive/Tom’s of Maine, Inc’s Sanford facility in the US in May 2024.
Authored by: Srinivas Churya In the pharmaceutical industry, analytical division and analytical laboratories plays a
Five different facilities of Eugia across India and US were inspected by USFDA between December
