Anatomy Of A GMP Vendor Qualification Program

By Laurie Meehan, Polaris Compliance Consultants, Inc.

Pharmaceutical companies are only as compliant as their vendors.  In a contract manufacturing arrangement, the manufacturer is held responsible for any cGMP deficiencies; however, you, as the sponsor or CRO, would be held responsible for your lack of vendor oversight.  Moreover, if your manufacturer fails to meet regulatory standards, you could lose millions in profits and patent exclusivity, damage your company’s reputation, and even jeopardize your entire business.

And that’s why a vendor qualification program is so critical.

There are a number of ways to slice and dice the process, but every robust vendor qualification program will include the following six activities.