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

Stability shelf-life. The PQRI Stability Shelf-Life Working Group was established in late 2006. The membership includes statistical and pharmaceutical scientists from industry, FDA, and academia.

The objectives of the group include:

  • Extending scientific knowledge with respect to evaluating pharmaceutical product stability data
  • Proposing best practices with respect to estimating stability quality attributes (i.e. shelf-life)
  • Investigating statistical methods for estimating shelf life consistent with FDA's QbD initiative.

The current activities of this group are centered on two primary topics. Consideration has been given to formal definitions of "shelf-life." The primary intention of a shelf-life claim is to provide a storage time during which it is ensured that the drug product (stability-limiting characteristics) remains within specification. Existing definitions are at best ambiguous when applied to designing statistical approaches to the analysis of stability data. Based on discussions within the working group and in public forums, the group is preparing a publication dealing with the fundamental issue of defining in a more formal manner shelf-life and related terms.

The second primary activity concerns developing and evaluating alternate statistical techniques for estimating shelf-life. The working group's efforts are directed toward providing an alternative methodology for estimating shelf-life that is predictive of future batch performance, and based in QbD philosophy. Among the approaches under consideration is a coupling of quantile regression and calibration techniques.

The work to date has been presented in several public forums including a PQRI-hosted webinar and various professional meetings (36).

Find out more

Additional information about PQRI is available on the organization's website. There you can learn about upcoming conferences and workshops, review past publications and regulatory submissions, and keep current on active projects. The website can be found at

Of course, PQRI is always looking for science-based research projects that it may take on in the future to help reduce regulatory burden and improve drug development, production, and testing. If you would like to submit such a request for research, the forms are available on the website. Also, if you would like to volunteer to be a member of an expert working group, you can indicate your interest. You will need to provide your member organization (e.g. AAPS), along with your areas of expertise and areas of interest.


It has been 10 years since the founding of PQRI. Based on the many significant project contributions and impacts of the institutes work, it is clear that the vision of the founders has been realized—with clear wins for the industry, academia, and regulatory agencies. PQRI provides a platform where dedicated volunteers with expert knowledge can work together to develop regulations based on sound science.

Gordon Hansen*, is vice-president of Analytical Sciences at Boehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury Rd., PO Box 368, Ridgefield, CT 06877-0368, tel. 203.798.5701,
and Chris Allen recently retired from Bayer Healthcare, where he was vice-president of product supply for the Consumer Care Division.

*To whom all correspondence should be addressed.


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