By Brittany Cloud, Eurofins Medical Device Testing
In recent years, the pharmaceutical industry has increased efforts to outsource many previous in-house activities, such as manufacturing, testing, and packaging. Naturally, this means increased scrutiny on both sides of the outsourcing partnership to ensure proper compliance and robust business practices. Since release of the 2015 US FDA guidance, Request for Quality Metrics, many firms are using metrics as a tool for assessing a contractor’s Quality Management System (QMS).
But numbers are only one factor when it comes to determining the amount of oversight needed to ensure cGMP compliance. Two questions remain: How should a firm evaluate whether a contract partner is the best fit for their intended needs? And, ultimately, how to determine the correct level of involvement needed to guarantee a successful relationship? One way to make this determination is to use the QUICK method. It offers a thorough and systematic process to holistically gauge the attributes of a firm that are critical to creating an effective outsourcing relationship. What exactly is QUICK?