How Indian Firms Are Rebooting For Quality Transformation
Against a backdrop of heightened regulatory scrutiny of manufacturing sites and processes, the heads of five top Indian firms told a recent forum in Mumbai how they are “rebooting” quality compliance and culture within their organizations. Tangible and intangible results are beginning to show but there is a long road ahead.
You may also be interested in...
Details in US FDA’s latest warning letter for Indian site suggest that firm’s data integrity remediation efforts are not up to scratch at least yet. Agency’s observations also highlight the potential complexities that may be on hand for Cempra’s antibiotic Solithera, recently hit by a complete response letter.
Analysts are cutting back profit forecasts for Indian generic giant Sun Pharma after the US FDA detailed a host of new testing and quality control issues at the company’s key Halol factory.
The leaders of six leading Indian firms were unequivocal that there is room for improvement on the quality front at a recent conference in Mumbai, but they also emphasized senior management engagement and resolve to get a "quality movement" going in their respective firms and in the domestic industry, in general.