The FDA issued a draft guidance for the pharmaceutical industry called, "Request for Quality Metrics," in an effort to help ensure manufacturers are producing quality medications.
"This document describes a set of measurements to help the agency evaluate the quality of the facilities and the processes that manufacturers use to make FDA-regulated drugs and biologics," wrote Ashley Boam and Mary Malarkey, in a FDA Voice blog post about the guidance. "These include prescription drugs and certain biological products. The guidance also encourages these manufacturers to conduct robust quality measurements on their own products."
Boam is FDA’s acting Director, Office of Policy for Pharmaceutical Quality, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research while Malarkey is FDA’s Director, Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research.
"We expect that these measurements will strengthen our efforts to ensure that FDA-regulated medications are not only demonstrated to be safe and effective, but also continually manufactured under strict quality standards," the blog post read. "We believe a careful analysis of quality metrics can help FDA better identify which facilities are at the highest risk for quality problems. This will help us use our inspection resources most efficiently and effectively."
ISPE sent an email Tuesday night addressing the new guidance.
"ISPE has been at the forefront of gathering clear and objective data through its Quality Metrics Pilot Program," the email read. "The first report, Quality Metrics Report - Wave 1, was published in June 2015. We are happy to report that all of the quantitative metrics identified by FDA this morning were studied and featured in the ISPE report. Additionally, Wave 1 included questions on process capability similar to those being considered by FDA as well as a comprehensive survey of quality culture and its impact on quality performance."
ISPE said they are, "reviewing the document and gathering member comments and suggestions to best provide an ISPE perspective to FDA on this guidance."
