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

December 11, 2000

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 FDA's Center for Drug Evaluation and Research (CDER), the pharmaceutical industry and academia--has 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 doesn't necessarily provide representative results. The FDA has agreed to release a revised draft guidance document on blend uniformity after receiving PQRI's recommendation.

PQRI will collaborate with the International Pharmaceutical Aerosol Consortium (IPAC) to address several issues associated with the chemistry, manufacturing and control requirements for oral and nasal inhalation products defined in draft FDA guidance. The specific issues to be studied are currently being identified.

PQRI is also considering an FDA request for help in addressing several issues associated with drug counterfeiting.

"FDA is extremely supportive of PQRI," said Helen Winkle, Acting Director, Office of Pharmaceutical Sciences, FDA. "FDA sees PQRI as an excellent means for leveraging intellectual and laboratory resources and promoting regulatory research programs to enhance our science base."
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About AAPS
AAPS is a professional, scientific society of more than 11,000 members employed in academia, industry, government and other research institutes worldwide. Founded in 1986, AAPS aims to advance science through the open exchange of scientific knowledge, serve as an information resource, and contribute to human health through pharmaceutical research and development. For more information about AAPS, visit AAPS Pharmaceutica at http://www.aapspharmaceutica.com.

American Association of Pharmaceutical Scientists

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