PQRI Participation

IPAC-RS is a member of the Product Quality Research Institute (PQRI). PQRI serves as a forum for academia, industry, FDA and USP to work cooperatively to conduct pharmaceutical product quality research and to support development of public standards and regulatory policy. Several of the PQRI working groups have specifically focused on regulatory science issues affecting orally inhaled and nasal drug products:

• Leachables and Extractables Testing;
• Particle Size Distribution Mass Balance; and
• Particle Size Distribution Profile Comparisons.

The workplans and minutes of these working groups explain the background, document the progress and point to the deliverables of these working groups. Further information about these and other PQRI activities is available through the PQRI newsletters and PQRI homepage.