IPAC-RS welcomes opportunities to address topics of mutual interest collaboratively with other organizations. For example, the following three specific initiatives were addressed through the Product Quality Research Institute:
Strategies for control of leachables and extractables in orally inhaled and nasal drug products
Role of cascade impaction mass balance
Characterization of the chi-square ratio test for in-vitro equivalence determinations
In collaboration with USP, IPAC-RS developed recommendations for microbiological testing of orally inhaled and nasal drug products
Through ISO, IPAC-RS in collaboration with EPAG is engaged in the development of international standards for inhalers and nebulizers.
A Quality-by-Design (QbD) approach to analytical methods development and registration is being discussed with a PhRMA analytical technical group. |