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.

NEW EVENTS
Dates	Event
April 14-15, 2027 SAVE THE DATES!	PQRI Workshop: Co-processed Excipients to Enhance Medicinal Product Development and Continuous Manufacturing To be held at USP (Rockville, MD) Hybrid Event Visit the Workshop webpage for more details.

NEWS

PQRI Strategic Plan 2023-2027: PQRI is pleased to announce the release of its 2023-2027 Strategic Plan. PQRI will continue to be a leading organization in creating best practices and conducting joint research in support of global pharmaceutical and biopharmaceutical regulation, leveraging its intellectual, scientific and technical resources to advance drug development and regulation to benefit patients. We encourage you to view the Plan. We extend a special thanks to the PQRI Board and Steering Committee for their leadership in connection with the development of this plan.

PQRI TiO2 Position Paper Available

The PQRI TiO2 Workshop Organizing Committee and workshop speakers prepared a PQRI position paper derived from the PQRI June 2023 TiO2 Workshop. The position paper provides an overview of the significant information that was presented by the expert speakers who participated in the workshop as well as ideas that were discussed during breakout sessions held to obtain broad feedback from the workshop participants on several key points related to TiO2 safety and the challenges of using TiO2 alternatives in many drug applications. The paper is available here.

PAST EVENTS
Dates	Event
October 30, 2025	PQRI PQTC Webinar: Understanding Complete Response Letters: Key Findings and Strategic Resolutions in Regulatory Affairs Below are links to the presentations. The webinar recording is available here. I. Welcome and Overview of Webinar (5 minutes) Moderator: Cat Vicente, Johnson & Johnson & PQRI PQTC Chair II. Presentations (15 minutes each) *Review of the FDA CRL Issue Facing Pharma Manufacturing* Glenn Wright, President & CEO, Parenteral Drug Association (PDA) *The Evolving Landscape of CRL Interpretation* Fidelle Jarmon, Vice President of Customer Engagement & Quality Partnerships, Minaris Advanced Therapies III. Open Q&A (55 minutes) All above plus Stelios C. Tsinontides, PhD, FAIChE, Vice President, Global Quality, Quality Management Systems, Transformation & External Advocacy, Merck & Co., Inc.
September 10-11, 2025	PDA/PQRI Advancing Artificial Intelligence in the Pharmaceutical Industry Workshop
February 28-29, 2024	PQRI Workshop: MIDD Approaches in Pediatric Formulation Development Click here for post-workshop information.
April 16-17, 2024	PQRI/EUFEPS 6th International Workshop – GBHI 2024 Click here for post-workshop information.
April 18, 2024	FDA/PQRI Workshop: Challenges and Opportunities for Modified Release Oral Drug Product Development – A Forum for Stakeholder Engagement Click here for post-workshop information.
September 26-27, 2023	FDA/PQRI Workshop on the Regulatory Framework for the Utilization of Artificial Intelligence in Pharmaceutical Manufacturing – An Opportunity for Stakeholder EngagementClick here for post-workshop information.
August 23, 2023	*PQRI Webinar: PFAS Restrictions – What you Need to Know and the Potential Impact Across the Pharmaceutical Industry and the Supply Chain Continuum*PQRI held a very important webinar to discuss the potential impact the polyfluoroalkyl substances (PFAS) ban proposed by the European Chemicals Agency (ECHA) may have on the supply of pharmaceutical products and the patients who use those products. This complimentary 90-minute webinar was held on August 8, 2023. A PDF copy of the presentations is available here. You can view the recording here.
June 13-14, 2023	***PQRI Workshop: TiO2 Use in Pharmaceuticals – Global Regulatory and Techn*ical ChallengesClick here for post-workshop information. A Workshop Summary is available here.Link to International Pharmaceutical Quality (IPQ) article on the Workshop.Link to the PQRI Position Paper (as noted above).If you missed the workshop and would like access to the Workshop recordings, please complete this registration for access** (for a nominal fee).

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. Recordings from past webinars are available for viewing at this link.

PUBLICATIONS

iBCS 1: Principles and Framework of an Inhalation-Based Biopharmaceutics Classification System (iBCS)

iBCS. 2: Mechanistic Modeling of Pulmonary Availability of Inhaled Drugs versus Critical Product Attributes

iBCS: 3 A Biopharmaceutics Classification System for Orally Inhaled Drug Products

iBCS: 4 Application of the Inhalation Biopharmaceutics Classification System to the Development of Orally Inhaled Drug Products

The PQRI iBCS Working Group has published four articles in Molecular Pharmaceutics. You can access a copy of these article by clicking on the titles above. PQRI thanks the iBCS WG for all their hard work.

The PQRI Standardization of in vitro predictive dissolution methodologies and in silico bioequivalence study Working Group has published two articles

- Article #1: Harmonizing Biopredictive Methodologies Through the Product Quality Research Institute (PQRI) Part I: Biopredictive Dissolution of Ibuprofen and Dipyridamole Tablets in the AAPS Journal (April 2023)
- Article #2: Advancing the Harmonization of Biopredictive Methodologies through the Product Quality Research Institute (PQRI) Consortium: Biopredictive Dissolution of Dipyridamole Tablets was published in Molecular Pharmaceutics (September 23, 2024).

PQRI thanks the Working Group for all their hard work.

The Product Quality Research Institute Elemental Impurity Interlaboratory Study: Results and implications for industry is now available.

This significant work was sponsored by PQRI and performed by a number of highly qualified analytical laboratories around the globe to investigate various analytical challenges related to the ICP-MS and XRF analysis of elemental impurities. The article is available here and here.

PQRI thanks the Elemental Impurities WG and in particular, the article authors, for their perseverance in bringing this study to its completion.

The PQRI Leachables and Extractables (L&E) Working Group provided recommendations to the US Food and Drug Administration in 2006 on safety thresholds and best demonstrated practices for orally inhaled and nasal drug products (OINDP). The published PQRI E&L recommendations for OINDP have been globally referenced by regulatory authorities. Risk for package-product interaction is highest in OINDP; however, there is a high risk of package-product interaction in parenteral drug products (PDP) and subsequently safety thresholds and best practices specific for PDP were developed. Threshold concepts introduced by OINDP were extrapolated for PDP, are based on daily dose, and include the safety concern threshold (SCT), the analytical evaluation threshold (AET) for compound identification, and the qualification threshold (QT) for identified non mutagenic compounds. The new Recommendation: “Safety Thresholds and Best Demonstrated Practices for Extractables and Leachables in Parenteral Drug Products” (Intravenous, Subcutaneous, and Intramuscular) describes the E&L strategy for PDP and provides examples for small and large volume parenterals with additional considerations for biological products. Studies to support characterization of materials and simulation for intended use are described with justification for solvent selection, exposure conditions, extract concentrations and analyses. Contributions were made by over ninety individuals who are highly experienced scientists including toxicologists, analytical chemists, and others from industry, and government. It is the hope and intent of the Working Group that the recommendations contained within this document will serve to guide the pharmaceutical development process for PDP and facilitate the approval and manufacture of safe, effective, and quality medicines. The members of the PDP E&L Working Group acknowledge PQRI and its member organizations for providing this forum to make this collaboration possible and the dedicated scientists and regulators that provided the essential information to make these recommendations possible. Available to download at the link above or at the PDA bookstore.

A companion document that summarized years of studying extractables and leachables in the niche field of ophthalmic drug products, entitled “Principles for Management of Extractables and Leachables in Ophthalmic Drug Products” is available in the PDA Journal of Pharmaceutical Science and Technology. PQRI thanks the authors and the broader PQRI-PODP Working Group for their hard work.