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Q Product Quality Research Institute

Welcome to the Product Quality Research Institute (PQRI) homepage with helpful information on member organizations, current and past projects, volunteer opportunities, and organizational structure.

Mission Statement

The Product Quality Research Institute (PQRI) is a non-profit consortium of organizations working together to generate and share timely, relevant, and impactful information that advances drug product quality and development.

By virtue of its diverse membership, PQRI provides a unique forum to focus critical thinking, conduct research, exchange information, and propose methodology or guidance to pharmaceutical companies, regulators, and standard setting organizations.

Member Organizations
PQRI Projects
Suggest a Project
PQRI Organizational Structure (PDF)

Genotoxic Impurities
Strategies for Identification and Control


PQRI is proud to announce the publication of the Leachables and Extractables Handbook: Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products, which has been compiled through the efforts of our Leachables & Extractables in Orally Inhaled Nasal Drug Products Work Group. This book is the result of several years of extensive research and group efforts to determine best practices for these drug products.


PQRI Calendar of Events

Dates Event
June 13-14, 2012 NIPTE Research Conference: Understanding Excipient Performance – Key to Successful QbD Formulation Design
Co-Sponsored with NIPTE
FDA Conference Facilities
White Oak, Silver Spring, MD
Sept. 5-6, 2012 PQRI Workshop on Application of IVIVC in Formulation Development
Co-sponsored with AAPS, FDA, FIP, and USP
Bethesda North Marriott
Bethesda, MD

Product Quality Research Institute
2107 Wilson Blvd, Suite 700, Arlington, Virginia 22201-3042, USA
703-248-4719, Fax: 703-525-7136 Email PQRI