Good Manufacturing Practices Supplier/Contractor Audit Lifecycle

The use of specialty manufacturers and contractors in the development and manufacture of pharmaceuticals and medical devices continues to rise. Along with this increase, there has been increased emphasis on the control of outsourcing as expressed in the FDA's Quality Systems Approach to the GMPs as well the International conference on Harmonization Q8 & Q10 guidance documents. The Quality Systems Regulation for devices discusses these controls in SubPart E, Purchasing Controls.

This presentation explains this lifecycle beginning with the decision to purchase or outsource and ending with maintaining continued qualification.