Remember that the CMO is an extension of the client. The client is responsible for the CMO. The quality unit in a company
should act as the "internal FDA"; if the unit is doing its job, FDA inspections will be painless (or, at least, less painful).
Develop relationships with CMO personnel; go beyond just a business relationship. Define a scorecard with KPIs. Hold each
other accountable. Quarterly business review meetings should be held and all decisions should be clearly documented. The client
should visit CMO facilities and know the processes. Most importantly, the client and the CMO should have open and honest communication
and build trust.
Chris Masterson is vice-president of quality at Cubist Pharmaceuticals, firstname.lastname@example.org
1. 21 CFR 200.10 Contract Facilities
2. FDA Safety and Innovation Act (FDASIA)
3. ICH Q10, Modern Pharmaceutical Quality Systems.