Quality Insights

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

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

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