In 2010, the global CMO market was estimated at $26 billion dollars. Year on year growth has been 10.7% since 2008. The increasing use of outsourcing in the pharmaceutical industry along with recent well-publicized quality issues with CMOs, make it a necessity to have excellent quality oversight of external manufacturers to provide assurance of GMP compliance. A Quality Agreement is one tool used to accomplish this objective.
A Quality Agreement is a contract between a pharmaceutical firm and a GMP Contract Manufacturer detailing the responsibilities of each party in assuring the quality, safety, and efficacy of the manufactured drug. Recently, the EU and the FDA issued regulatory guidance to bring some clarity and consistency to these quality contracts:
- EU GMP Chapter 7 "Outsourced Activities" (Revised)
- Draft Guidance for Industry - "Contract Manufacturing Arrangements for Drugs: Quality Agreements" May 2013