Blend Uniformity and Content Uniformity in Oral Solid Dosage Manufacturing: an IQ Consortium Industry Position Paper.

Abstract

The IQ Consortium Uniformity Testing Working Group reviewed the current BU and CU testing practices among ten member companies. All ten companies presented their current approach to BU and CU testing at the three stages of Product Lifecycle Management: the Process Design Stage, the Process Qualification Stage, and the Continuous Verification Stage. With this information on hand, the Uniformity Testing Working Group members developed a risk-based approach to BU and CU testing, and proposed innovative methods to reduce or eliminate blend sampling based on risk to Uniformity of Dosage Unit (UDU) testing. This approach uses prior knowledge, mechanistic understanding, and structured risk assessment tools to classify formulations as low-risk or high-risk, thus guiding the testing strategy. A decision tree was outlined on this basis for low-risk and high-risk formulations. The Working Group aims to influence health authorities on the matter, enabling streamlined testing expectations.