On the potential impact of linguistic nuances in regulatory interactions

The event A three-day pharmaceutical manufacturing conference hosted by ISPE in Mumbai in October 2018. The highlight of the event was the presence of senior members of the US FDA who presented current trends, their experiences auditing in India and other international locations, and their expectations from Indian companies w.r.t. quality of drugs. The most […]

Eliminating offline TOC and conductivity for WFI

I have come across several organizations who have state of the art Water for injection (WFI) generation and distribution plants with on-line conductivity and TOC measurement but continue to rely on off-line measurement and testing in QC labs. It is often a big challenge to convince users, system owners, and the testing team to fully […]