GMP Tips - Ranbaxy's Continuing Woes, and What We Can Learn from Them - Oct 14, 2008

You may have been watching the continuing saga of one of the worlds largest providers of generic drugs, Ranbaxy Laboratories, based in India, and their problems meeting US FDA’s GMP requirements. FDA has been in discussions with Ranbaxy Laboratories for several months concerning two facilities. After much discussion and what it deemed inadequate responses from the drugmaker, the FDA decided to issue the two Warning Letters and to encourage the confiscation of products coming from the two facilities into the United States.

Read the two Warning Letters. Also read an article from Forbes and a news account from a publication in India. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resources Articles and scroll down.

GMP Training Tip
Use information from these Warning Letters to make your GMP training sessions come alive and relevant. Learning from OPE, Other People's Experience, is a good and easy way to keep your company in a healthy compliance mode.

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