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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
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
*Postponed* PQRI Workshop on Biosimilars - How Close is Close Enough—The workshop is being postponed at this time. More information will follow regarding the rescheduling of the workshop.x
USP Meeting Center
Rockville, Md.

May 20-21, 2013

USP Workshop on Pharmaceutical Packaging: Moisture Permeation and Integrity Testing
Cosponsored by USP and PQRI
USP Meeting Center
Rockville, Md.

December 9-10, 2013 Suitability and Compatibility for Packaging and Delivery Systems: Extractables and Leachables
Cosponsored by USP and PQRI
USP Meeting Center
Rockville, Md.

January 14-15, 2014

PQRI Workshop on Nanomaterial Drug Products
USP Meeting Center
Rockville, Md.


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