Advancing Product Quality: a Summary of the Inaugural FDA/PQRI Conference

Abstract

Abstract. On September 16 and 17, 2014, the Food and Drug Administration (FDA) and Product Quality Research Institute (PQRI) inaugurated their Conference on Evolving Product Quality. The Conference is conceived as an annual forum in which scientists from regulatory agencies, industry, and academia may exchange viewpoints and work together to advance pharmaceutical quality. This Conference Summary Report highlights key topics of this conference, including (1) risk-based approaches to pharmaceutical development, manufacturing, regulatory assessment, and post-approval changes; (2) FDA-proposed quality metrics for products, facilities, and quality management systems; (3) performance-based quality assessment and clinically relevant specifications; (4) recent developments and implementation of continuous manufacturing processes, question-based review, and European Medicines Agency (EMA)-FDA pilot for Quality-by-Design (QbD) applications; and (5) breakthrough therapies, biosimilars, and international harmonization, focusing on ICH M7 and Q3D guidelines. The second FDA/PQRI conference on advancing product quality is planned for October 5-7, 2015.

The Role of Public–Private Partnerships in Catalyzing the Critical Path

“…The Product Quality Research Institute (PQRI) and the National Institute for Pharmaceutical Technology and Education (NIPTE) are supporting efforts to promote commercial‐scale product quality and efficient manufacturing. PQRI addresses a wide range of manufacturing topics, including life‐cycle management to detect drifts in manufacturing process and approaches to shelf‐life estimation of pharmaceutical products . Through their product‐quality research, PQRI have provided evidence‐based recommendations to the FDA regarding manufacturing standards, which have informed numerous regulatory guidances for a broad range of topics ( Table ).…”

“…PQRI addresses a wide range of manufacturing topics, including life-cycle management to detect drifts in manufacturing process and approaches to shelf-life estimation of pharmaceutical products. 61,62 Through their product-quality research, PQRI have provided evidence-based recommendations to the FDA regarding manufacturing standards, which have informed numerous regulatory guidances for a broad range of topics ( Table 3).…”