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 The FDA has agreed to release a revised draft guidance document on blend uniformity after receiving PQRI s recommendation. 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 sees PQRI as an excellent means for leveraging intellectual and laboratory resources and promoting regulatory research programs to enhance our science base.