Article | May 18, 2016

Following FDA Guidance: Continuous Improvement In An Outsourced Environment

Source: Dassault Systemes Americas

By Justin Neway and Eda Ross Montgomery

Following FDA Guidance

In May 2013 the U.S. Food and Drug Administration (FDA) released its draft guidance, “Contract Manufacturing Arrangement for Drugs: Quality Agreements,” with recommendations representing its “current thinking on defining, establishing, and documenting the responsibilities of each party (or all parties) involved in the contract manufacturing of drugs subject to Current Good Manufacturing Practice (CGMP). In particular, we describe how parties involved in the contract manufacturing of drugs can utilize Quality Agreements to delineate their responsibilities and assure drug quality, safety, and efficacy.”