Friday, July 3, 2009

FDA Publishes Paper on cGMPs (Current Good Manufacturing Practices)

The Food and Drug Administration (FDA) just released this paper, Facts About Current Good Manufacturing Practices (cGMPs). They've published it because of the recent rash of regulatory actions they've taken against drug manufacturers for not following cGMPs. They say:

Current Good Manufacturing Practices (cGMPs) for human pharmaceuticals affect every American. Consumers expect that each batch of medicines they take will meet quality standards so that they will be safe and effective. Most people, however, are not aware of cGMPs, or how FDA assures that drug manufacturing processes meet these basic objectives. Recently, FDA has announced a number of regulatory actions taken against drug manufacturers based on the lack of cGMPs. This paper discusses some facts that may be helpful in understanding how cGMPs establish the foundation for drug product quality.
Knowing about and following cGMPs is critical for drug and supplement manufacturers. As a consumer it's important for me to know that there's oversight. Cheers to compliant and ethical manufacturers. 

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