In hundreds of inspections carried out by FDA since 2009—based on inspection observations released by FDA, many dietary supplement contract manufacturers have been found to be deficient in basic areas of cGMPs (current good manufacturing practices). So it is important for distributors who outsource their manufacturing activities to ensure their suppliers are compliant with the cGMPs and other applicable regulations. Creating simple, efficient and cost-effective ways to pre-select potential contract manufacturing partners prior to engaging in a formal contract is crucial to both the quality of the final product and the success of the partnership. Due diligence at the early stages of engagement increases the chances that the final firm selected will be compatible with the own-label distributor’s business needs and the requirements for cGMP compliance…
I will speak on “How to Audit and Qualify Suppliers for cGMP Compliance” as part of the GMP Workshop at SupplySide West. The three-hour workshop will take place on Friday, Oct. 9, at Mandalay Bay in Las Vegas. Visit http://west.supplysideshow.com/workshops.aspx for the complete agenda and to get registered.