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FDA, drug industry and scholars find success in effort to tackle regulatory issues

Product quality research institute formulates plan to improve pharmaceutical approval and testing policies

ARLINGTON, Va. The Product Quality Research Institute (PQRI)a first-ever collaborative effort between the FDAs Center for Drug Evaluation and Research (CDER), the pharmaceutical industry and academiahas identified issues related to the regulation of pharmaceuticals and is carrying out research which will have an impact on the establishment of testing standards and controls for drug products.

PQRI was established one year ago to streamline drug approval and testing policies while ensuring the highest level of product quality. PQRI is administratively managed by the American Association of Pharmaceutical Scientists (AAPS).

In its first year, PQRI identified seven "working groups" to address the following regulatory issues: blend uniformity, manufacturing changes, packaging changes, bulk drug post-approval changes, drug substance impurity testing, drug substance particle size analysis, and topical and aerosol forms.

"Based upon our first experience with the Blend Uniformity Working Group, the PQRI process is working," said Tobias Massa, Ph.D., PQRI Steering Committee Chair. "It shows that this process can indeed be successful in addressing regulatory issues. The key is that, for the first time, we have FDA, academia and regulated pharmaceutical manufacturers collectively working together."

The Blend Uniformity Working Group is expected to make recommendations to FDA by early next year on science-based changes to regulations for blend uniformity testing. These recommendations will ensure that there is thorough mixing of the drug within the blend and dosage unit. Current regulations advocate the testing of each production batch of a powder-blend drug. However, industry experience suggests that testing every batch is not necessary or meaningful because the current blend sampling technology is flawed and doesnt necessaril
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Contact: Debbie Werfel
werfeld@aaps.org
703-248-4743
American Association of Pharmaceutical Scientists
11-Dec-2000


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