Product Quality Research Institute
What is PQRI?
The Product Quality Research Institute (PQRI) was established in 1999, and brings together members of the pharmaceutical industry, academia and regulatory agencies to develop science-based approaches to regulation. Since its inception, PQRI has coordinated the volunteer work of industry and agency scientists and academics to conduct in-depth studies of a broad range of technical issues important to the pharmaceutical and biopharmaceutical industry. PQRI is a unique organization in which scientists and experts from industry, regulatory agencies, and academia collaborate closely to develop work products in direct support of regulatory guidance. PQRI and its mission is singularly relevant given the current rapid growth in new and varied drug product modalities, advancements in manufacturing paradigms, and the ever increasing need for efficient but high quality research, development and manufacturing frameworks.
Through its Technical Committees and working groups, PQRI tackles projects to ensure the quality, safety and performance of drug products. We invite you to learn more about our current projects, meetings, and publications. See About PQRI for more information.
|PQRI Overview Presentation 2020 (PDF)|
|PQRI Organizational Structure (PDF)|
|PQRI Strategic Plan 2018-2022|
|4th PQRI Workshop on ICH Q3D Elemental Impurities Requirements(November 9-10, 2020): Registration is now open. For information and updates visit the Workshop webpage.
|UPDATE: The PQRI Parenteral and Ophthalmic Drug Product Leachables and Extractables (PODP L&E) Working Group has recently posted a brief update on their work to develop a risked–based approach for evaluation and safety qualification of leachables in PODPs.
To justify the use of safety thresholds for identification and risk assessment of PODP leachables, the group conducted and evaluated the results of extraction studies on polymeric materials and evaluated a database of over 600 potential leachables.
Based on their findings, the Working Group has developed a set of best practices for parenteral drug products, which is summarized in this update and will be described in more detail in a forthcoming publication.
|FREE PQRI WEBINAR SERIES: PQRI’s Biopharmaceutics Technical Committee (BTC) is continuing its free webinar series presented by subject matter experts in the pharmaceutical sciences. This is a unique opportunity to learn about the latest research and regulatory trends on a variety of topics and interact with other experts in real-time all over the world without the need for travel. See below for information on upcoming and past webinars.
|November 9-10, 2020||4th PQRI Workshop on ICH Q3D Elemental Impurities Requirements. VIRTUAL EVENT
Registration is open. Click here to register.
For information and updates visit the Workshop webpage.
|September 16, 2020
|BTC Webinar Series: Regulatory Requirements and Scientific Considerations for Biosimilar Products
Click to view the webinar recording.
PDFs of the presentations are available here:
Emerging Scientific Considerations in the Development of Bisimilars
|July 29, 2020||
BTC/PQTC Webinar Series: Excipient Considerations for Parenteral Drug Development
Click to view the webinar recording.
PDFs of the Presentations are available here:
Thomas Tice presentation available upon request, for a copy of the presentation, please contact the PQRI Secretariat.
|April 28, 2020|
|October 10, 2019|
|April 9-11, 2019|
|Biopharmaceutics Technical Committee Webinar Series||See BTC website for 2018 and 2019 webinar recording links.|
|April 18-19, 2018|