Best Practices for Managing Quality and Safety of Foreign Particles in Orally Inhaled and Nasal Drug Products, and an Evaluation of Clinical Relevance
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In a previous paper, the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS) outlined the progression of regulatory recommendations for foreign particles in orally inhaled and nasal drug products (OINDP), techniques for evaluating foreign particles, and proposed approaches for developing safety thresholds for such particles (1). In this paper we expand on some of the key ideas proposed in that first article. We present here best practices for managing quality and safety of OINDP with respect to foreign particles, based on quality by design concepts, we provide an update on current assessment techniques, and finally we examine the clinical relevance of some representative OINDP foreign particles.
QUALITY BY DESIGN
Industry is specifically interested in effective and efficient ways to manage the quality and safety of OINDP with respect to foreign particles. One way to achieve this is through a “quality by design” approach proposing that...
KeywordsDrug Product Active Pharmaceutical Ingredient Foreign Particle Routine Quality Control Total Daily Intake
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