DELIVERY SYSTEMS WORKSTREAM
OINDP MATERIALS WORKING GROUP
The OINDP Materials Working Group 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.
February 9, 2017
Recommended Baseline Requirements for Materials used in Orally Inhaled and Nasal Drug Products
By Working Group: OINDP Materials. February 9, 2017 (published)
DEVICE WORKING GROUP
The objective of the Device Working Group is to understand and promote best practices for OINDP device design. The WG was formed to prepare and conduct a Device Design session at the IPAC-RS 2008 Conference, and has since published on the same topic, developed and conducted a survey on testing needed to support device changes, and presented at the IPAC-RS 2011 conference on the topics of "Regulatory Expectations for User Testing" and "Human Factors and the Design of Inhalation Devices."
The Device Working Group is active in the areas of device change management, knowledge space and design space and human factors. The group has completed a white paper proposing a risk-based approach to management of device changes, and is developing voluntary guidelines for approaching knowledge space and design space. Group members are also considering opportunities to improve instructions for use, an integral part of the user interface for devices.