CDER Wants Firms to Achieve Quality Management Maturity

CDER says it will apply an intense focus to encourage the pharmaceutical industry to achieve “quality management maturity.” Delivering a Center update at the Food and Drug law Institute’s annual meeting 5/21, CDER director Patrizia Cavazzoni said that despite the overwhelming pandemic-related ongoing work, product quality remains a priority this year. “We are putting a lot of effort into evolving from the ‘ticking the box’ cGMP paradigm to really embracing ICH Q10 and then using Q10 as a launch pad to fully realizing the 21st century pharmaceutical quality vision, which is quality management maturity.

cGMP establishes a minimum standard for systems that assure proper design, monitoring, and control of manufacturing processes and facilities, according to Cavazzoni. “ICH Q10 outlines an effective pharmaceutical quality system applied throughout the product lifecycle to facilitate innovation and continual improvement and strengthen the link between pharmaceutical development and manufacturing activities.”

Cavazzoni said quality management maturity (QMM) is really striving to require a transparent method of evaluating and communicating the maturity of the quality management system for facilities. “We have a multidisciplinary multicenter working group that is facilitating the development of a QMM rating program for manufacturers,” she said. Two pilot programs are ongoing — one is focused on finished dosage forms and domestic manufacturers, and the other is focused on foreign manufacturers and active pharmaceutical ingredients. Site assessments began this month and will run until the end of September. “We will use that information and other information to formalize criteria to objectively measure a manufacturing site’s quality management maturity, and that’s really going to get us to a more modern paradigm to manage quality in manufacturing facilities,” she told the meeting.

Cavazzoni said the pandemic has also led CDER to improve its supply chain surveillance, which will continue after the pandemic is over. “CDER had a well established drug shortage surveillance program that proved itself, for instance, in the aftermath of Hurricane Maria,” she explained. “What we realized very quickly in the pandemic is that we needed to expand it and to develop a way to look at the supply chain and potential early signals of shortages to complement our established drug shortage program. She said the program is being expanded to include not only those critical drugs that were initially determined to be the focus during the pandemic, but now to a larger number of drugs and essential medicines.

The new surveillance system is anchored by technology, including workflow management, and analytics. The framework gathers information to identify key signals, according to Cavazzoni. Data the agency is looking at include facility quality, supply chain diversification, purchasing trends, past shortages, hospital utilization and projected demand, among other factors.