Industry Responds to FDA Metrics Program
08. September 2015
After nearly three years of workshops, white papers, and pilot tests, one might expect some agreement between FDA and manufacturers of drugs and biologics on how to measure the quality and reliability of production systems and resulting products. A draft Request for Quality Metrics guidance published July 28, 2015 by the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) outlines an initial set of metrics that the regulators believe will help field inspectors assess the ability of an operation to produce high quality medicines on a reliable basis.