By: Sandra K. Rodriguez, Market Analyst
FDA “Encourages” Industry to Volunteer for e-Inspections Program
Based on Quality Metrics, FDA’s e-Inspections program is encouraging industry to implement state-of-the-art, innovative quality management systems for pharmaceutical manufacturing. In response to stakeholder feedback, the agency issued a revised draft guidance document in November 2016 titled “Submission of Quality Metrics Data.”
The draft guidance explains how the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) intend to utilize submitted data and quality metrics to help ensure that their policies and practices continue to support continuous improvement and innovation in the pharmaceutical manufacturing industry. For more background on the evolution of this initiative see ISPE, FDA and the Metrics Future and FDA to Grade Industry on a Curve – Are You Ready?