New PQRI Technical Group to Work with FDA's Initiative on Good Manufacturing Practices

ARLINGTON, Virginia (August 21, 2002) — The Product Quality Research Institute (PQRI) supports the Food and Drug Administration's new initiative to improve the Good Manufacturing Practice (GMP) regulations. As noted by Dr. Janet Woodcock, Director, FDA Center for Drug Evaluation and Research, PQRI will play a significant role in this effort. The institute looks forward to participating in the process outlined by the FDA today.

PQRI has recently established a Manufacturing Technical Committee to seek scientific-based solutions to manufacturing and GMP issues of mutual concern to the industry and the FDA. The committee will identify scientific issues that relate to GMP practices and policies. One of the first issues to be addressed by this technical committee will be various aspects of aseptic processing.

Dr. Tobias Massa, Executive Director of Regulatory Affairs at Eli Lilly and Chair of the PQRI Scientific Steering Committee, said, "PQRI is an established, non-partisan entity, well-positioned to address GMP issues. Industry, academia and the FDA are currently working together under the auspices of PQRI on a number of key product-quality regulatory projects. Expanding our portfolio to include GMP issues is a logical extension of our on-going efforts to facilitate the development of appropriate science-based regulatory standards to assure the continued manufacture of high-quality pharmaceutical products."

About PQRI
PQRI was established in 1999 to streamline drug approval and testing policies while ensuring the highest level of product quality. PQRI brings together for the first time the innovator and generic pharmaceutical industry, academia and the FDA Center for Drug Evaluation and Research to address issues related to pharmaceutical product quality. The ultimate goal of PQRI is to develop scientific knowledge that will result in appropriate changes to regulatory policies that will, in most cases, be less burdensome. As a not-for-profit 501(3) entity, PQRI relies solely on individual industry contributions as its primary source of operating funds.

For additional information on PQRI visit www.pqri.org. Calls and questions may be directed to Sylvia Gantt, PQRI office at 703-248-4719.

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