PDA Letter Article

A QUICK Guide To Selecting a CMO

by Brittany Cloud, Eurofins Lancaster Laboratories, Inc.

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).