LIVE FROM CPhI Worldwide: Raising the Bar on GMPs Needs to Continue Via Technology

"Current GMPs are not up to par in India and China,” Ram Balani, CEO and founder of FDASmart, a company that provides consulting and training services to the pharmaceutical and biotech industry in the U.S. and Asia, told attendees at his Education Workshop Tuesday.

A pilot program from 2008 to 2010 encouraging cooperation between the FDA, TGA, and EMA started the process moving in the right direction. No one wishes to see a repeat of the contamination of Heparin in Changzou, China that led to 149 deaths, or the Ranbaxy US FDA “meltdown” that ended with the banning of exports of nearly 30 generic drugs produced by that company in India, he say.

Balani admits that the globalization of the pharmaceutical industry has made it difficult to send inspectors on-site. All the same, “senior management has to own up to supply chain oversights,” Balani says.

APIs accounted for more than 50 percent of inspections in 2004, 66 percent of foreign inspections and 43 percent of U.S. audits by the CDER yielded 483s in 2002. “’Out of sight, out of mind’ is dead,” Balani says. “We’ve moved on to the era of ‘trust, but verify.’”

Technology will eventually improvethe process, he says, citing one called Smartinspect that uses live streaming technology over the internet.

"There is technology out there that will help us solve global GMP inconsistencies. They won’t fix the problem, but they will put us on the right track,” he says.