In 2011, China’s State Food and Drug Administration (SFDA) completed ten GMP inspections of firms in the US, the EU, South Korea and India that manufacture vaccines, APIs, biologics, and oral solid dosage forms and sell their products in China.
The overseas inspections were announced last October (IPQ “The News in Depth” Nov. 10, 2011), and were conducted at firms that had previously agreed to participate and help SFDA develop and hone its inspection procedures.
At the Food and Drug Law Institute (FDLI) Annual Meeting in late April in Washington, DC, Sidley Austin Beijing Office Partner Chen Yang shared the inspection numbers, and explained that SFDA plans to continue the inspections.
“I think in the long run, to the extent that SFDA has the resources, it will definitely perform more inspections at foreign facilities,” Yang commented. “I think it is also a learning process for them to understand how the new GMPs work.”
In 2010, SFDA rolled out a major revision to its GMPs (IPQ “The News in Depth” Nov. 10, 2011), and the new standards – in many respects similar to the US and EU GMPs – are being used by SFDA in the foreign inspections.
Before the new GMPs were released, Yang noted, “the inspectors had a form and were checking boxes. Now they need to look deeper into the documentation and the problems the firms have.”[/membership]