FDAnews
www.fdanews.com/articles/120736-fda-proposes-streamlined-framework-for-combo-product-cgmps

FDA Proposes Streamlined Framework for Combo Product cGMPs

September 24, 2009
Makers of components in co-packaged or single-entity combination products would have two options for showing compliance with current good manufacturing practices (cGMPs) for drugs or biologics and quality system requirements for devices under a new proposed rule. For co-packaged or single-entity combination products, the rule proposes that companies demonstrate compliance with all cGMP regulations for each part of the product or use a streamlined approach.
Drug Industry Daily