FDA requires that Virtual Sponsors demonstrate adequate quality oversight over the manufacturing  of their drug products.  For many years Sponsors would rely entirely on the contracted manufacturers and labs to step in and provide the quality framework.  But the 2016 guidance, "Contract Manufacturing Arrangements for Drugs: Quality Agreements Guidance for Industry" made it clear that the Sponsor MUST demonstrate control and take responsibility for the quality of the drug products.  

At a minimum this entails the use of Quality Agreements (aka Quality Technical Agreements) that outline the various roles and responsibilities of each party.  The Sponsor (often referred to as the Contract Giver) and the CMO (often referred to as the Contract Acceptor) each have defined roles within the document including everything from approval of raw material specifications to final release of the product.  Sponsor involvement is required even if you are a one or two person shop and don't have anyone with a QA title on staff yet.  A simple set of SOPs that keep these ultra-lean Virtual Sponsors in mind are essential to ensuring these roles are clearly understood and maintained throughout the life of the program.  In future posts we will examine specific aspects of quality agreements and what we have seen over our 30 years of writing, reviewing, and negotiating the elements of these agreements with manufacturers from around the globe.