Inhalation

INH0219

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Inhalation FEBRUARY 2019 5 documentation guidelines, and development of the drug/device combination products guideline). Materials and Plume Characterization Working Groups e Materials Working Group co- ordinated with the GRRO China Group for a presentation on chemical and materials risk man- agement at the China National Pharmaceutical Packaging Associ- ation (CNPPA) Suzhou Dialogue Conference in August. ey also gave a presentation on biocom- patibility at the AAPS CDG/ NIFDC/IPAC-RS workshop. In addition, the group held a work- shop for pharmaceutical and de- vice manufacturers and suppliers, addressing quality of materials. e workshop themes were based on the group's baseline require- ments document for materials quality. Speakers and participants included industry, standards orga- nizations and the FDA Center for Devices and Radiological Health (CDRH). e program and slides for the workshop are available on the IPAC-RS website. After presenting results from its benchmarking survey on plume geometry at RDD 2018, the Plume Characterization Working Group conducted a second survey on spray pattern. e group plans to submit a poster abstract on their work to Respiratory Drug Deliv- ery (RDD) Europe 2019. Population Bioequivalence; Product Quality and Cascade Impaction Working Groups e Population Bioequivalence (PBE) Working Group has com- pleted its technical report regard- ing the performance of the PBE in vitro test (from the FDA indi- vidual-product BE guidelines) when applied to impactor-sized mass (ISM), using industry's da- tabase of real-products' cascade impactor data. e Product Quality Demonstra- tion Strategy (PQDS) Working Group conducted a webinar on PQDS and spearheaded the draft- ing of the IPAC-RS comments on the in-process revision of USP chapter <601>, "Inhalation and Nasal Drug Products—Aerosols, Sprays, and Powders—Perfor- mance Quality Tests" [PharmFo- rum 44(5)]. e IPAC-RS Cas- cade Impaction Working Group (CI WG) also made important contributions to those comments. e CI WG has also continued the preparation of a multi-part manuscript on best cascade im- pactor practices for dry powder inhaler testing. Future events Further details on these and oth- er developments will be present- ed in future IPAC-RS workshops and public webinars. For more information on IPAC-RS, please visit www.ipacrs.org. Medical Devices Made Easy www.merxin.com info@merxin.com Tel: +44 (0)1223 787300 MRX003 is a "505j" generic capsule inhaler for tiotropium DPI. It is the only "off-the-shelf " commercially available "505j" opportunity for tiotropium DPI in the industry. MERXIN: Reduce Cost, Reduce Risk, Increase Success. GENERIC & CUSTOMISED MRX003 is a "505j" generic capsule inhaler for CUSTOMISED

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