Introduction

One (1) of the timeless principles of commerce is caveat emptor (latin for, “Let the Buyer Beware”). Under the principle of caveat emptor, the buyer takes the responsibility for the condition of the items or quality of the services that he or she purchases. Prior to the current consumer protection laws, buyers had no warranties for the goods or services that they purchased. Today, most states require goods to be of “merchantable or sellable quality”. As this condition is often next to impossible to define and enforce, buyers are advised to embrace the principle of caveat emptor prior to “signing on the dotted line”.

While being conscious of the products and services purchased is good practice for consumers and most businesses, it is a regulatory requirement for pharmaceutical and biopharmaceutical manufacturers. For these organizations, the decisions where to purchase raw materials, components, manufacturing and testing equipment, and even consulting services, need to be well informed (and documented). The results of making poor purchasing decisions can lead to situations that impact product quality, regulatory compliance, company profits, and even the reputation of the company.

This article presents a practical and compliant methodology for pharmaceutical and biopharmaceutical companies to qualify vendors and hence make well informed purchasing related decisions.