India Quality Forum: What Regulators Really Want
This article was originally published in Scrip
Executive Summary
Indian industry head honchos, some of whose plants are currently under regulatory scrutiny for cGMP deviations, were all ears at the recent India Pharmaceutical Forum 2016, as top regulatory officials flagged up what they find of most concern. Data integrity issues set off "alarm bells" for regulators, they said, and "scapegoating" of very junior people is no way to handle quality deviations. Moreover, developing a sustainable culture of quality is critical to achieve excellence, the meeting heard.