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 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 The FDA has agreed to release a revised draft guidance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.”
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 www.aapspharmaceutica.com.
# # #
| 
