Monday, November 19, 2007

China Gets Serious on Drug GMP - Nov 19, 2007

Effective January 1, 2008, China's State FDA will no longer tolerate the detection of any "severe defects" during a GMP accreditation process, meaning that such a finding will result in automatic failure.

China has only been requiring pharmaceutical manufacturers to comply with GMP since 2004, and has granted accreditation if less than three "severe defects" are discovered. An example of a "severe defect" is the falsification of application documents.

The US FDA and China's SFDA have been working together for the past six months on a safety pact between the two countries. Looks like there's some real progress being made here.

Read the entire news account. Go to:
http://gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

To our US based readers, have a Happy Thanksgiving holiday.
Read FDA's article - Home for the Holidays: Preventing Foodborne Illness at Family Gatherings
Find it at http://www.cfsan.fda.gov/~dms/fdholida.html

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