Quality Insights

Imprimis Recall Unapproved Ophthalmic In

Imprimis NJOF recalled three intraocular ophthalmic injection drug products in December 2025 (as per USFDA

Qvents Apps and Tools For QMS and GMP Pr

Qvents provides useful tools for QMS processes – Risk Assessments, Continuous Process Validations, Supply Chain Traceability

Nitrosamine Impurities in Pharmaceutical

Qvents Apps & ToolsNitrosamine and NDSRI Risk Assessment Tools – APIs, Drug Products, Excipients, Water

Supply Chain Traceability of Medicinal P

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

Continuous Process Verification (CPV) an

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

Excipient Risk Assessment: Approach, Tem

Qvents Apps & Tools Access the Excipient Risk Assessment Tool – Click Here According to

Qualification of Inhouse Reference Stand

Authored by: Srinivas Churya This Quality Insight post presents a concise approach for selection and

Purified Water System Qualification and

The FDA inspected Colgate-Palmolive/Tom’s of Maine, Inc’s Sanford facility in the US in May 2024.

Strengthen Analyst Qualification, Reduce

Authored by: Srinivas Churya In the pharmaceutical industry, analytical division and analytical laboratories plays a

Deficiencies That Lead to Officiation Ac

Five different facilities of Eugia across India and US were inspected by USFDA between December