CMO Supplier Quality Agreements - How to Comply with New FDA and EU Guidelines for Contract Drug Manufacturing
Objectives of the Presentation
- The Who and What of a good Quality Agreement
- What a Quality Agreement is - and is not
- Responsibilities of the owner vs. contract facility
- GMP responsibilities
- A comparison of the new guidelines from the FDA and the EU
Why Should you Attend
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)
- Guidance for Industry - "Contract Manufacturing Arrangements for Drugs: Quality Agreements" Nov 2016