In August 2013, the FDA announced the withdrawal of its draft guidance document for industry, Powder Blends and Finished Dosage Units – Stratified In-Process Dosage Unit Sampling and Assessment. The primary reason for the withdrawal of the draft guidance document was that Sections V and VII no longer represented the Agency’s current thinking. See Questions and Answers from the FDA.
At the same time, FDA stated that the USP <905> Uniformity of Dosage Units should not be applied for product release testing due to concerns that the results of the test did not provide sufficient assurance that future samples taken from the batch would also comply with the same acceptance criteria.
The withdrawal of the document and FDA’s lack of confidence in the results from USP <905> Uniformity of Dosage Units testing resulted in uncertainty for manufacturers, but also presented an opportunity for developing a modernized approach to enforcing the GMP requirements in this area.
An ISPE Technical Team explored alternative approaches to assess Blend and Content Uniformity (BUCU).
For more information, contact RegulatoryAffairs@ISPE.org.