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The Product Quality Research Institute (PQRI; www.pqri.org) was established in 1999 as a nonprofit consortium of organizations, including standard setting and regulatory agencies, working together to generate and share timely, relevant and impactful information that advances global drug product quality, manufacturing and regulation. 6 April 2024 Inhalation CROSS-INDUSTRY Organizations Introduction to PQRI e Product Quality Research Institute (PQRI; www.pqri.org) was established in 1999 as a non- profit consortium of organiza- tions, including standard setting and regulatory agencies, working together to generate and share timely, relevant and impactful information that advances global drug product quality, manufactur- ing and regulation. PQRI remains a forum for scientists from indus- try, academia and regulatory agen- cies to tackle a broad range of technical issues important to the pharmaceutical and biopharma- ceutical industry. rough the joint activities conducted by the technical committees and work- ing groups, PQRI produces high- impact work products to advance drug development, manufacturing and regulation to benefit patients. PQRI member organizations include: • US Food and Drug Adminis- tration (FDA) • Health Canada (HC) • International Pharmaceutical Aerosol Consortium on Regu- lation & Science (IPAC-RS) • International Pharmaceutical Excipients Council of the Americas (IPEC-Americas) • Extractables and Leachables Safety Information Exchange (ELSIE) • Parenteral Drug Association (PDA) • United States Pharmacopeia (USP) PQRI technical and scientific initiatives In 2023, PQRI member organi- zations worked together to deliver a portfolio of projects with high value to industry and regulators. e Biopharmaceutics, Develop- ment and Product Quality Techni- cal Committees drove important and timely technical and scien- tific initiatives with the vision of advancing drug product quality, manufacturing and regulation. One significant effort conducted by PQRI was a response to the proposed ban of per- and poly- fluoroalkyl substances (PFAS) by the European Chemicals Agency (ECHA). PQRI developed a ques- tionnaire, which was completed by PQRI members as well as other stakeholders in the industry, to capture the scale of the impact that the proposed PFAS restrictions would have across the pharmaceu- tical supply chain. Following the survey, PQRI conducted a pub- lic webinar to raise awareness of this issue, and developed a posi- tion paper that was submitted to ECHA, which outlined the par- ticular scientific challenges faced in replacing PFAS and PFAS- containing products. A copy of the position paper is available on the PQRI website. e Product Quality Technical Committee (PQTC) managed a number of important initiatives within its portfolio. e Elemen- tal Impurities Working Group and the AI Application in Contin- uous Process Verification (CPV) Working Group prepared man- uscripts that will be submitted for publication soon. Also, under the PQTC's oversight, a study on Flow Restrictor Delivery Systems in OTC Children's Medication was completed. e Biopharmaceutics Techni- cal Committee (BTC) contin- ues to drive several initiatives in topic areas including pediatric formulation assessment, crystal structure prediction, inhalation biopharmaceutics, long act- ing injectables, model informed drug development, in vivo pre- dictive dissolution methodolo- gies, bioequivalence of additional strengths of modified release products and patient centric specifications. e PQRI Stan- dardization of in vitro Predictive Dissolution Methodologies and in silico Bioequivalence Study Working Group published the article, "Harmonizing Biopre- dictive Methodologies rough the Product Quality Research Institute (PQRI) Part I: Biopre- dictive Dissolution of Ibuprofen and Dipyridamole Tablets" in the AAPS Journal. e Inhala- tion Biopharmaceutics Classifi- cation System (iBCS) Working Group presented at conferences, including DDL and ISAM, and prepared several manuscripts. e third article, "iBCS:3. A Biopharmaceutics Classifica- tion System for Orally Inhaled Drug Products," was recently published in the ACS Journal, Molecular Pharmaceutics. 2023 Activities and accomplishments of the Product Quality Research Institute (PQRI) Glenn E. Wright, MS and Mary Kate Bielinski, BS On behalf of the Product Quality Research Institute (PQRI)