FDA HOLDING CGMP WORKSHOPS IN CHINA
The FDA is hosting a series of workshops in China aimed at educating participants on methods for complying with current good manufacturing practices (cGMP).
The workshops, which will be held in collaboration with Peking University and the International Society for Pharmaceutical Engineering, will occur Dec. 5-7 and April 24-26, 2006, in Beijing. The agency said the workshops are targeted at a variety of pharmaceutical professionals, including process/production engineers, manufacturing personnel, quality assurance/quality control managers, regulatory affairs professionals, consultants, regulatory investigators and cGMP compliance officials.
U.S. firms have increasingly been turning to China for active pharmaceutical ingredients and other services, but experts have warned that the majority of Chinese firms don't abide by FDA regulations. Of the approximately 4,200 pharmaceutical plants currently operating in China, only 51, or 1.2 percent, have passed FDA inspections, according to one industry expert.
For more information about the workshops, go to http://www.fda.gov/OHRMS/DOCKETS/98fr/cd0534.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/cd0534.pdf).