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The Product Quality Research Institute (PQRI) is a non-profit consortium of organizations, including standard-setting and regulatory agencies, working together to generate and share timely information that advances global drug product quality, manufacturing and regulation. PQRI was established in 1999 to create a safe haven in which scientists from industry, academia and regulatory agencies could collaborate. 6 April 2023 Inhalation CROSS-INDUSTRY Organizations • iBCS 1: Principles and Frame- work of an Inhalation-Based Biopharmaceutics Classifi- cation System (https://pubs. acs.org/doi/full/10.1021/acs. molpharmaceut.2c00113) • iBCS. 2: Mechanistic Model- ing of Pulmonary Availability of Inhaled Drugs versus Criti- cal Product Attributes (https:// pubs.acs.org/doi/10.1021/acs. molpharmaceut.2c00112) e BTC organized hot topic dis- cussions covering the development of long-acting injectables and chal- lenges in the development of for- mulations for pediatric patients. PQRI plans to organize a workshop in 2023 related to the latter topic. In 2022, the BTC also held a webi- nar on Approaches to Establishing Bioequivalence Safe Space for Orally Administered Drug Products: Ap- plications and Case Studies. Development Technical Committee (DTC) e DTC produced many impact- ful deliverables in 2022 including a webinar on the Extractables and Leachables Testing for Transdermal Delivery Systems, which focused on regulatory and scientific chal- lenges associated with the execu- tion of extractable and leachable studies for transdermal delivery systems, and explored how prin- ciples of safety thresholds may be applied. e DTC's Intercon- nectability between Vial Container Closure Systems/Vial Transfer De- vices Working Group presented their work at the 2022 PDA Par- enteral Packaging Conference. e DTC's Parenteral and Ophthal- PQRI member organizations col- laborate to tackle industry and regulatory concerns, needs and trends. Members also engage with other key stakeholders and im- pact global regulatory standards and guidance. In November 2022, PQRI partnered with the FDA to host a workshop on the Regula- tory Framework for Distributed and Point-of-Care Pharmaceutical Manufacturing. is event brought together leaders from regulatory agencies, industry and academia to facilitate interaction among DM/ POC stakeholders on critical areas for development and implementa- tion of these technologies. PQRI technical and scientific activities e Biopharmaceutics Technical Committee, Development Techni- cal Committee and Product Quality Technical Committee drive PQRI's scientific activities by addressing ongoing regulatory and scientific issues, and delivering a high-value portfolio of projects to industry and regulators. Biopharmaceutics Technical Committee (BTC) e BTC had a highly productive year. e BTC's Inhalation BCS Working Group came together as a partnership between indus- try, academia and the FDA to develop an inhalation-based bio- pharmaceutics classification sys- tem (iBCS). e Working Group presented at multiple conferences and had two manuscripts pub- lished in Molecular Pharmaceutics: An overview of PQRI The Product Quality Research Institute (PQRI) is a non-profit consortium of organizations, in- cluding standard-setting and reg- ulatory agencies, working together to generate and share timely infor- mation that advances global drug product quality, manufacturing and regulation. PQRI was established in 1999 to create a safe haven in which scientists from industry, academia and regulatory agencies could collaborate. In 2022, PQRI continued to produce impactful work product as a leading organi- zation leveraging its intellectual, scientific and technical resources to advance drug development and regulation to benefit patients. PQRI member organizations Current PQRI member organiza- tions include: • US Food and Drug Administra- tion (FDA) • Health Canada • Consumer Healthcare Products Association (CHPA) • Extractables and Leachables Safety Information Exchange (ELSIE) • International Pharmaceutical Aerosol Consortium on Regu- lation & Science (IPAC-RS) • International Pharmaceutical Excipients Council of the Amer- icas (IPEC-Americas) • Parenteral Drug Association (PDA) • United States Pharmacopeia (USP) An update from the Product Quality Research Institute (PQRI) Glenn E. Wright, MS and Mary Kate Bielinski, BS On behalf of the Product Quality Research Institute (PQRI)