FDA Office of Pharmaceutical Quality Initiatives & 2016 Priorities

Dr. Michael Kopcha, Director, Office of Pharmaceutical Quality, CDER, FDA, delivered the keynote address on the second day of the ISPE/FDA/PQRI Quality Manufacturing Conference, June 7, 2016. Dr. Kopcha presented an overview and update on FDA’s Office of Pharmaceutical Quality (OPQ). OPQ, a single unit in Center for Drug Evaluation and Research (CDER) dedicated to drug product quality and close integration of the agency’s major functional areas, advances FDA’s quality initiative to the next level. “OPQ’s mission is simple and straightforward,” he told conference attendees. “We want to make sure quality medicines are available to the American public.” Its vision is a global benchmark for regulation of pharmaceutical quality, and its slogan is “one quality voice.” The OPQ is focused on quality, enhancing regulation to balance risk and availability. “We always put patients first,” Kopcha said, “but we want to balance potential quality risks with the risk of a patient not getting a drug.” He said the agency tries to anticipate quality problems before they develop to help prevent drug shortages. “It’s not going to happen overnight,” he conceded, “but eventually, we will get there.” Another OPQ priority is innovation. "To drive quality we must drive new technology and manufacturing science,” he says. OPQ is also focused on building collaborative relationships by communicating openly, honestly, and directly. "No one can operate on their own,” he stated. Not just within industry, but within FDA itself." OPQ works with other FDA offices to monitor and assess drug quality and safety. “We don’t want to pull products off the market,” Kopcha said. “We don’t want to make your life difficult. But if we see problems, we have to alert the industry.” In 2015, OPQ met or exceeded all performance goals performance goals and played a critical role in CDER’s approval of several high-profile “firsts,” including the first continuous manufacturing process and the first 3D-printed drug product. For 2016, the Office of Pharmaceutical Quality is focused on four priorities:

• A more rigorous and comprehensive approach to drug quality surveillance and inspection. “Consistency is what we’re driving for,” Kopcha explained. “We also need a common informatics platform” that integrates the knowledge captured during review, inspection, and surveillance activities.
• Team-based quality assessments that integrate quality review with inspection results for more informed decision-making on facility acceptability and application approvability. This helps build an integrated knowledge base that identifies product risks, quickly addresses quality problems, and improves overall efficiency and effectiveness in managing the drug product life cycle.
• Formal risk-based regulatory approaches that effectively define the scope and extent of quality assessments. “Where are the risks? That’s where we need to focus our time and attention,” Kopcha said. Currently OPQ employs a formal risk assessment process to best allocate resources based on product risk and patient impact. “We want to develop a unified risk evaluation for brand and generic products. Make sure your generics have the same standards and are in developed in a similar—not identical—way,” he added.
• A collaborative approach with manufacturers that encourages innovation and the adoption of new technologies. “OPQ prioritizes a collaborative approach with manufacturers that encourages innovation and the adoption of new technology,” Kopcha said. The agency’s Emerging Technology Team is exploring such topics as continuous manufacturing, 3D printing of drug products, novel aseptic filling technology, and new container/closure systems.

“Our common goal is drug product quality,” Kopcha said. “There needs to be a conversation, and it needs to go both ways. It has to be a dialogue, a discussion. Let us communicate, collaborate, and work together to deliver a high quality product that meets the patient’s needs – a true partnership.” Save the date for the 2017 Quality Manufacturing Conference in Arlington, VA on 5 – 7 June 2017.   Sign-up to receive early bird registration notifications for the 2017 Quality Manufacturing Conference.