Rapid Quality Transformation

Executive Summary

The U.S. Food and Drug Administration (FDA) performs an essential public health task by ensuring that safe and effective drugs are available to maintain/improve the health of people in the United States.

Our team explored ways to improve communications with drug manufacturers after the FDA found problems at their plants. There are instances where time delays to effectively correct manufacturing quality problems identified during FDA inspections have resulted in drug shortages, questionable drug quality, or clinical adverse events.

FDA and industry stakeholders informed us that increased communication soon after the inspection could improve the quality and speed of a firm’s response and enable industry to efficiently focus resources on effective corrective actions. We conducted a prototype test using a mock post-inspection meeting. Feedback from the meeting participants confirmed that direct communication in a structured meeting assisted in understanding FDA’s concerns and finding better corrective actions.

Thus, we envision a process where industry can meet with FDA after inspections to better understand FDA concerns and identify effective solutions. The goal is to improve the firm’s risk assessments and root cause analysis which a firm will use to expeditiously implement corrective actions that improve the quality of the drug products manufactured.

A project supported by the: HHS Ignite Accelerator

Team Members

David Jaworski (Project Lead), FDA
Diane Raccasi, FDA
Steve Wolfgang, FDA
Rob McElwain, FDA
Sarah Barkow, FDA

Milestones

March 2016: Project selected into the HHS Ignite Accelerator
July 2016: Time in the Accelerator ended
August 2016: Management concurrence to proceed with development of Project Charter
December 2016: Anticipated Project Charter approval

Project Sponsor

Paula Katz, Division Director, Center for Drugs Evaluation and Research, FDA