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

Funding and support

PQRI was incorporated as a nonprofit corporation and the initial thought was that very little funding would be necessary. As mentioned above, AAPS provided office space and technical support to PQRI. After a few years, it became clear that a source of stable income was necessary in order to secure ongoing support for maintaining administrative activities, including a full-time administrative assistant. As a result, annual membership dues were implemented. These dues were set at the minimum level required to support administrative activities. The various members of the board of directors, steering committee, technical committees, and working groups all provided their efforts on a volunteer basis free of charge.

Initially, PQRI research consisted of collecting and compiling existing scientific information, which was then used as a basis for sound scientific decisions. AAPS provided office space and administrative support and committee meetings were held in member organization offices.

However, it was soon recognized that some of the questions brought up did not have answers readily available either in the literature or through data provided by member organizations (data mining). As a result, the working groups reported to their technical committee chairs the need for PQRI to conduct independent research in addition to literature searches and data mining.

Of course, projects requiring research resulted in the need for additional funds. Appeals were made to the pharmaceutical and allied industries for financial support, and several companies, recognizing the importance of the PQRI initiative, made significant contributions to the research fund. The appeals were answered very clearly and decisively, with approximately $500,000 collected to support independent research projects being conducted or planned (25).

Another source of research funding for the organization came through the various seminars and workshops conducted. All extra funds generated through these activities have been channeled back into the organization's research.

This robust, multisource funding mechanism has provided PQRI the ability to fund multiple research projects that benefit the industry, the public, and the regulatory agencies.

Some notable PQRI achievements

It is beyond the scope of this article to review all of the significant activities and accomplishments of PQRI since its inception. Instead, a selection of some of the arguably most successful projects will be reviewed, along with a discussion of the impact the outcomes of these projects have had on the pharmaceutical industry.

Blend uniformity. It was a common industry observation, and a significant problem, that samples of powder taken from a blended mixture did not show the same degree of active-dose uniformity as was seen in samples of compressed tablets taken from the press. One possible reason for this discrepancy was that the small sample of tablets tested was not really representative of the content uniformity of the batch. Another possibility was that sampling the powder blend introduced sampling biases that were not evident when sampling compressed tablets. Due to this uncertainty, the regulatory proposal was to test all blends for content uniformity of the active ingredient(s) and reject any batches that did not meet established criteria.

The Blend Uniformity Working Group conducted extensive data mining and statistical analysis studies that confirmed the superiority of testing compressed tablet samples provided that a statistically valid sample was analyzed. An enhanced tablet-testing scheme was proposed and was adopted by FDA in 2003 as an alternate to the expensive and time-consuming blend-uniformity testing proposal (26). The resulting recommendation addressed both FDA and industry concerns by substantially enhancing product quality assurance without increasing the regulatory burden.

Aseptic processing. Another major problem tackled by a PQRI working group was related to aseptic processing. The goal of this project was to address key issues in the FDA's concept paper "Sterile Drug Products Produced by Aseptic Processing" (27). While not all areas of the concept paper were addressed, the 8 clarifications and 10 recommendations were developed by the working group based on the expert knowledge of the working group members, survey results, and publications where applicable and were presented in the final guidance document issued by FDA (28).


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