Product Quality Responsibilities Shared Between CMOs and Sponsor Firms Under FDA Scrutiny

FDA is putting industry on notice that relationships between sponsors and contract manufacturing organizations (CMOs) will be receiving close attention during upcoming agency inspections.

The growing agency focus on the relationship between marketing application holders and their CMOs received attention at the PDA/FDA meeting in mid-September in Washington, DC.

Among those commenting on the issue was CDER Office of Compliance Division of Manufacturing and Product Quality (DMPQ) Director Richard Friedman.

As a result of the “undoubtable trend toward outsourcing,” FDA is paying closer attention to contract relationships, Friedman stressed, and sponsors “should expect to hear questions during inspections about how their companies are making sure that their CMOs are actually being monitored.”

He pointed to quality agreements and communication/notification mechanisms as items the agency would examine closely – for example, notifications from CMOs to sponsor firms when an out-of-specification (OOS) result occurs.

In these “shared manufacturing agreements,” the DMPQ director emphasized, issues discovered at a CMO have been leading to subsequent inspections and enforcement actions at the sponsor firm.

[More on FDA’s focus on the shared responsibility between sponsor firms and CMOs, and a discussion of a recent warning letter exemplifying this focus, are provided for subscribers here.  For an inspector’s view on  potential problems in contracting relationships see IPQ “In the News” June 18 story FDA Wants to See More Transparency Between Drug Companies and Contractors on Sponsor’s Application and Contractor’s GMP Status.   For subscription information, click here.]