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

Organizational structure

It was recognized by the early PQRI organizers that a formal structure would be required in order to manage the various projects planned for the institute. After extensive discussions a plan was established to have the institute managed by two governing bodies: a board of directors vested with administrative management and fiduciary duties and a steering committee responsible for all activities related to management and direction of scientific activities.

Table I: Committee and working group structure of the PQRI.
The PQRI board of directors comprises five individuals, three of whom are appointed by the AAPS executive council and two representing the steering committee. Current practice is that the chairman and vice-chair of the steering committee sit on the board of directors and provide the link between the two groups. The steering committee itself was set up to provide each of the member organizations with input into the scientific decision making and project goal setting for the organization. A system of technical committees and working groups was established by the steering committee to carry out and manage the projects (See Table 1).

Figure 1: PQRI current organizational structure and committee membership. (Figure courtesy of PQRI)
A chart of the current organizational structure of PQRI is provided in Figure 1. Overall, it has changed only slightly from the arrangement established when the group was incorporated.

Each PQRI project has a working group comprised of subject-matter experts recruited from the member organizations. These working groups generate, evaluate, and discuss information or data, and develop PQRI recommendations, technical reports, and scientific papers. They also coordinate conferences, workshops, seminars, and forums to collect input from the larger scientific community and to share the information they have gathered on the specific subject evaluated.

Each working group operates under the guidance of a technical committee. Currently there are three technical committees within PQRI that provide technical and scientific guidance, direction and review for PQRI working groups. The technical committees consist of scientists and regulatory experts from industry and the FDA, and make technical/scientific recommendations to the steering committee.

The current PQRI technical committees are:

  • Development Technical Committee (DTC). The mission of the DTC is to conduct research projects which help to more clearly define through technical examples and applications the quality by design (QbD) concepts, science or related activities associated with QbD in the context of drug development. The DTC incorporates projects formerly managed by the Drug Product and Drug Substance Technical Committees.
  • Manufacturing Technical Committee (MTC). The MTC leverages manufacturing expertise to define science-based approaches that appropriately integrate risk assessment and encourage innovation and continuous quality improvement in pharmaceutical manufacturing as well as flexibility in the associated regulatory processes.
  • Biopharmaceutics Technical Committee (BTC). The mission of the BTC is to promote research in the area of biopharmaceutics. Areas of interest include: linkage of in-vitro drug dissolution/release methods to in-vivo drug bioavailability and bioequivalence, methods for the determination of bioavailability and bioequivalence, pharmacokinetic-pharmacodynamic relationships, and comparative clinical trials.

Table II: Summary of technical committee and working group activities.
The activities of past and present technical committees and working groups are presented in Table II. Most teams meet regularly by conference call and periodically face-to-face. The length of time required for a group to complete a project varies considerably but often requires many months to complete.

An expanded summary of PQRI activities and publications can be found on the institute's website (24).


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