FDA’s Office of Pharmaceutical Quality Reports on 2023 Quality Assessments

On April 3, 2024, FDA’s Center for Drug Evaluation and Research (CDER) announced the release of the 2023 annual report of the Office of Pharmaceutical Quality (OPQ). The report provides a look back at the office’s accomplishments in quality assessments, inspections, surveillance, research, and policy making (1). OPQ performed quality assessments on more than 1100 approved drug applications in 2023 and conducted more than 60 pre-license inspections in 18 countries and 10 states. The office also participated in the release of 10 guidance documents and authored 90 articles promoting best practices and science-based improvement.

The office uses four priorities for assuring drug quality: collaboration, communication, engagement, and innovation. OPQ’s collaboration efforts included supporting 55 novel drug approvals that included 17 biotechnology products. The office helped expedite 359 quality assessments in order to address drug shortages and performed 28 priority assessments for orphan disease treatments.

Communication efforts including publishing seven Manuals of Policy and Procedures and two compliance programs. Staff also participated in public workshops, conferences, and webinars more than 350 times in 2023. Furthermore, a report on pharma quality was published in June of 2023.

OPQ forged partnerships and connections in 2023 that included developing 12 CDER workshops and events and hosting the biennial Pharmaceutical Quality Symposium. The office also participated in the development of seven international quality guidelines, participated in 119 US Pharmacopeia expert bodies, and evaluated two submissions with other global regulators in international pilot programs.

Innovation efforts included the acceptance of 15 proposals to the Emerging Technology Program, hosting workshops on artificial intelligence and advanced technologies, and the use of the Knowledge-aided Assessment and Structured Application to assess approximately 1400 applications.

CDER’s OPQ office oversees the assurance that medicines in the US market meeting quality requirements. It reviews both domestic and foreign drug manufacturing for new and generic drugs, biologics, and over-the-counter products. OPQ operates as the lead for pre-license inspections of manufacturing facilities and acts as subject matter experts on preapproval inspections. The office uses surveillance to continuously monitor the quality of products and alert consumers to potential risks.

“The strategic pillars of collaboration, communication, engagement, and innovation support OPQ’s core functions. Collaboration strengthens OPQ’s culture and relationships with FDA business partners. Communication allows OPQ to elevate awareness and commitment to the importance of pharmaceutical quality. Innovation works to promote the availability of better medicines for the American public, while engagement forges partnerships and connections with public stakeholders,” the report states.

In 2024, OPQ has reorganized to “adapt to the changing pharmaceutical landscape by being more agile and efficient.” The office has consolidated research functions into a single office to improve coordination and manage lab-based resources. A new Office of Quality Assurance has been created to foster improvement and staff development. Existing assessment functions have been placed in new Offices of Product Quality Assessment I, II, and III to “encourage a lifecycle focus and agility in responding to an evolving workload.”

Reference

FDA. Office of Pharmaceutical Quality, 2023 Annual Report (CDER, OPQ, April 2024).