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Friday, May 7, 2010

Manual on GMPs & SOPs


We have become aware of a new manual from the American Herbal Products Association (AHPA) that provides guidance as well as templates for preparing Standard Operating Procedures (SOPs) for compliance with Dietary Supplement Good Manufacturing Practices (GMPs).  Having SOPs is an important part of complying with FDA’s GMP regulations, which are effective for even the smallest companies this June.  According to our FDA contacts, inspections of dietary supplement companies will begin in earnest.

You can learn more about the manual by visiting the AHPA site at .

Our goal at Bioscience Translation & Application is to further our clients’’ success while helping them ensure they are compliant with applicable FDA regulations.  Contact us for help with SOPs, GMPs or other FDA regulations.

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