FDA Integrated Quality Assessment - PQRI

1 FDA Integrated Quality Assessment Ashley B. Boam, MSBE Acting Director office of Policy for pharmaceutical Quality CDER/ office of pharmaceutical Quality FDA/PQRI Conference on Advancing pharmaceutical Quality October 6, 2015 Tony Tong, PhD Vice President Head of Development, Pomona Teva Pharmaceuticals Objectives Explain the Integrated Quality Assessment , how it was developed, and how it is being implemented in OPQ Discuss trends in FDA s requests for additional information/deficiencies when applications have been reviewed using the IQA approach (for brand and generic drug products) How experience in biotech products can shed light on the integration of review and inspection as part of the IQA process 2 office of pharmaceutical Quality (OPQ) A single unit in CDER dedicated to drug product Quality The creation of one Quality voice, streamlining Quality oversight throughout the lifecycle of a drug product Encourages use of modern, more efficient manufacturing technologies Establishes consistent Quality standards and clear expectations for industry Balances potential Quality risks with the risk of a patient not getting a drug Anticipates Quality problems before they develop to help prevent drug shortages 3 How will we achieve these goals?

2 Maximize focus and efficiency by applying risk-based approaches Enhance Quality regulation by developing and utilizing staff expertise Strengthen the effectiveness of lifecycle Quality evaluations by using team-based processes Provide effective leadership by emphasizing cross-disciplinary interaction, shared accountability, and joint problem solving The Integrated Quality Assessment 4 Integrated Quality Assessment A team-based Integrated Quality Assessment (IQA) approach maximizes each team member s expertise and provides aligned, patient-focused, and risk-based drug product Quality recommendations, inclusive of drug substance, drug product, manufacturing, and facilities OPQ teams work in a highly collaborative model Teams collaborate effectively within timelines Collaborations/discussions should involve key stakeholders (including ORA) Communication/discussion of Quality risk and link to the patient are critical to effective Quality recommendations 5 How is IQA different from previous process?

3 OPQ process uses: expert teams concurrent Assessment single review template scheduled team meetings Pre-OPQ process uses: one application, one reviewer independent Assessment separate templates Inconsistent communication between disciplines 6 Session Overview Evolution of the CMC Review for NDAs Sarah Pope Miksinski, FDA Evolution of the CMC Review for ANDAs Susan Rosencrance, FDA Evolution of Quality Assessments - Recent Trends in FDA Queries Mike Saleh, Pfizer BREAK Integrated Quality Assessment - ANDA Perspectives Siva Vaithiyalingam, Teva Challenges Integrating Regulatory Filings and Pre-Approval Inspection with the Expectations of Current Regulatory Guidance Tony Mire-Sluis, Amgen Panel Q&A 7