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Since the mid-1990s, substantial progress has been made toward improving the quality of medicinal products through collaborative efforts of various health authorities, pharmacopoeial and industry organizations. These efforts have focused on utilizing a science-based and risk-based approach, where product and process understanding are critical to the development and manufacture of high-quality medicinal products. 22 OctOber 2024 Inhalation Point of view: A better way to set specifications and control quality—General concepts and examples An opinion article by representatives of the IPAC-RS Product Quality Demonstration Strategy (PQDS) Working Group Helen Strickland, MSc a ; J. David Christopher, MSc b ; Beth Morgan, PhD c ; Greg Larner, MSc d and Svetlana Lyapustina, PhD e a GSK b Merck & Co. c AstraZeneca d Independent Statistical Consultant e Faegre Drinker Consulting Introduction Since the mid-1990s, substantial progress has been made toward improving the quality of medicinal products through collaborative efforts of various health authorities, pharmacopoeial and industry organizations. ese efforts have focused on utiliz- ing a science-based and risk-based approach, where product and process understanding are critical to the development and manufacture of high-quality medicinal products. As a result, the numerous indus- try guidances, issued over the past 30 years, reflect a significant change in the product quality standards that pertain to the registered chemistry, manufactur- ing and controls (CMC) information required for regulatory approval of a medicinal product. For example, the International Council for Har- monisation (ICH) Q10 "Pharmaceutical Quality Systems (PQS)" guidance establishes a quality stan- dard for the use of a Product Lifecycle Model [1], which is represented graphically in Figure 1. In 2018, the United States Food and Drug Administra- tion (FDA) issued a draft guidance [2] for industry that set forth the quality expectations for developing and manufacturing metered dose inhalers (MDIs) and dry powder inhalers (DPIs). is draft guidance had been updated to reflect current standards and requirements for submitting CMC information in FDA regulatory filings and incorporates the elements of the ICH Q10 product lifecycle model. In turn, the PQS model described in ICH Q10 is "based on International Standards Organization (ISO) quality concepts, includes applicable Good Manufacturing Practice (GMP) regulations and complements ICH Q8 Pharmaceutical Development and ICH Q9 Quality Risk Management" [1]. Based on the FDA's current experience for MDIs and DPIs, product specifications approved using a tra- ditional development approach were recommended for the critical quality attributes (CQAs) linked to the Quality Target Product Profile (QTPP) elements. e statistical concepts briefly referenced in the ICH Q8, ICH Q9 and ICH Q10 guidances are based on a set of International Organization for Standardization (ISO) standards that underpins a statistical framework designed to assure the quality objectives required to successfully achieve product realization [3]. As indicated in the draft guidance, delivered dose uniformity (DDU) for MDIs or uniformity of dos- age units (UDU) for DPIs and aerodynamic particle size distribution (APSD) should be included in the analytical procedure and specified acceptance criteria associated with e.g., USP <601> for DDU or USP <905> for UDU, respectively. e product specifica- tions recommended for DDU and UDU correspond to a quality standard defined in terms of how test statistics calculated from a set of test results will be