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

作者：Yu Lawrence X^*; Baker Jeffrey; Berlam Susan C; Boam Ashley; Brandreth E J; Buhse Lucinda; Cosgrove Thomas; Doleski David; Ensor Lynne; Famulare Joseph; Ganapathy Mohan; Grampp Gustavo; Hussong David; Iser Robert; Johnston Gordon; Kesisoglou Filippos; Khan Mansoor; Kozlowski Steven; Lacana Emanuela; Lee Sau L; Miller Stephen; Miksinski Sarah Pope; Moore Christine M V; Mullin Theresa; Raju G K; Raw Andre; Rosencrance Susan; Rosolowsky Mark; Stinavage Paul

来源：AAPS Journal, 2015, 17(4): 1011-1018.

DOI：10.1208/s12248-015-9754-4

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.

• 出版日期2015-7
• 单位MIT