Anatomy Of A GMP Vendor Qualification Program

ByLaurie 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 companys reputation, and even jeopardize your entire business.

And thats 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.

Develop Service Requirements

In this step, the sponsor outlines all requirements and considerations relevant to vendor selection. At a minimum, these will include:

Cull Vendor List

In this step, youll assess whether potential vendors are able to meet the requirements you defined in step 1.Your QA department will also want to assess the vendors compliance status by searching the FDA website for import alerts, recalls, and warning letters.A questionnaire should be used to collect important information about a vendor such as:

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Anatomy Of A GMP Vendor Qualification Program