Bringing a Science-Based Approach to Regulation: The Story of the Product Quality Research Institute - Pharmaceutical Technology

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Bringing a Science-Based Approach to Regulation: The Story of the Product Quality Research Institute
The authors describe the development and organization of the Product Quality Research Institute and highlight some of the important projects conducted by its Working Groups.


Pharmaceutical Technology
Volume 33, Issue 12

The Product Quality Research Institute (PQRI) was established in 1999 as a vehicle to bring members of the pharmaceutical industry, academia and the US Food and Drug Administration (FDA) together to develop science-based approaches to regulation. Since its inception, PQRI has coordinated the volunteer work of industry and agency scientists and academics as they conducted in-depth studies of various technical issues important to the pharmaceutical industry.

History of PQRI

The concept of establishing a safe haven in which scientists from the pharmaceutical industry and the FDA could meet to conduct research to support the development of science-based regulatory policy was the brainchild of Roger Williams, who was at the time director of the FDA Office of Pharmaceutical Sciences. The concept was based on the then novel idea that regulation should be based on science.

Initial discussions of the concept transpired at an ad-hoc meeting in 1995 between Williams and representatives of a number of key drug industry trade associations. Follow-up meetings took place in which representatives from academia were included, and in October 1996, the Product Quality Research Initiative was publicly proposed for the first time. A steering committee was established to formalize the initiative. Bylaws were established and approved on June 10, 1999, and on Aug. 2, 1999, the State Corporation Commission of Virginia officially recognized the Product Quality Research Institute, Inc. (PQRI) as a nonprofit, tax-exempt corporation.

The significance of the PQRI concept was quickly recognized and the idea of PQRI was strongly endorsed by senior FDA leadership from the beginning. This was demonstrated by the statement issued by Jane Henney, MD, then FDA commissioner:

"PQRI is a tangible expression of a unique collaboration between academia, industry, and a governmental agency that brings us together for both the innovator and generic pharmaceutical companies. This collaboration will identify the best practices for manufacturing of high quality pharmaceutical products. It's an excellent means for leveraging FDA's intellectual and laboratory resources; to promote regulatory research programs designed to enhance the science base that we need to provide, and I am convinced it will be a win, win, win solution for the public, the industry, and the agency" (1).

As one of the founding members of PQRI, the American Association of Pharmaceutical Scientists (AAPS) played a significant role in providing substantive 'bricks and mortar' and managerial support to the fledgling institute. AAPS helped PQRI get off the ground and their support continues to this day. PQRI shares office space with AAPS in Arlington, Virginia, where PQRI has its only paid employee, an executive secretary.

The original member organizations of PQRI were:

  • American Association of Pharmaceutical Scientists (AAPS)
  • Consumer Healthcare Products Association (CHPA)
  • Generic Pharmaceutical Industry Association (GPhA)
  • National Association of Pharmaceutical Manufacturers (NAPM)
  • National Pharmaceutical Alliance (NPA)
  • Parenteral Drug Association (PDA)
  • Pharmaceutical Research and Manufacturers of America (PhRMA)
  • U.S. Food and Drug Administration, Center for Drug Evaluation and Research (FDA, CDER)

The membership quickly grew to include:

  • United States Pharmacopoeia (USP)
  • International Society of Pharmaceutical Engineers (ISPE)
  • International Pharmaceutical Excipients Council -Americas (IPEC-Americas)
  • International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS)
  • Biotechnology Industry Organization (BIO) The current membership of PQRI consists of:
  • American Association of Pharmaceutical Scientists (AAPS)
  • Consumer Healthcare Products Association (CHPA)
  • United States Pharmacopoeia (USP)
  • International Pharmaceutical Excipients Council -Americas (IPEC-Americas)
  • International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS)
  • US Food and Drug Administration, Center for Drug Evaluation and Research (FDA, CDER)
  • Health Canada

As of November 2009, the Parenteral Drug Association has withdrawn its membership in PQRI.

In 2007, PQRI expanded its scope internationally by including Health Canada as a second member regulatory agency.


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