IPAC-RS Updates Recommended Baseline Requirements for Materials used in OINDPs

Working Group:

OINDP Materials

Baseline Requirements for Materials used in Orally Inhaled and Nasal Drug Products (OINDP) 2017 describes requirements for materials used to manufacture components for OINDP, and is the first revision of the original document presented in 2011.   This revision is primarily driven by changes in the regulatory landscape since 2011.  The impetus for this document was based the a need that arose out of several discussions between pharmaceutical manufacturers, regulators and multiple suppliers in meetings sponsored by IPAC-RS.   OINDP manufacturers can use this document to guide primary packaging/device or production material selection and control; suppliers can use the document to provide appropriate materials and information.

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