DELIVERY SYSTEMS WORKSTREAM
OINDP MATERIALS WORKING GROUP
The OINDP Materials Working Group (WG) objectives are to improve materials quality and integrity, reduce supply chain challenges, and advance the science and regulation related to ensuring drug delivery system materials and component quality. The WG does this through engagement with regulatory agencies and standard-setting bodies world-wide, development of scientific, peer-reviewed publication(s), presentations at leading conferences, development of workshops and training courses, survey and webinars, and active engagement with supply chain partners.
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The WG is releasing the updated Recommended Baseline Requirements for Materials used in Orally Inhaled and Nasal Drug Products (OINDP). This document describes baseline requirements for materials used to manufacture components for OINDP, and is the second revision of the original document presented in 2011. The first revision was issued in 2017. This current revision is primarily driven by changes in the regulatory and standards landscape since 2017.