21 CFR 111 Compliance
The FDA has issued the final rule establishing regulations to require current good manufacturing practices (CGMPs) for dietary supplements. These new regulations will require that dietary supplement manufacturers put into place proper controls to insure that dietary supplements are processed in a consistent manner and meet quality standards. The final rule has been staggered over a three-year period based on the size of the organization. The final CGMPs are effective June 2008 for large companies, June 2009 for companies with less than 500 employees, and June 2010 for companies with less than 20 employees.
GQA can assist in the assessment and development of quality systems to meet this new standard. Contact us to discuss your specific needs.