2023 FDA Science Forum
Risk-Based Blend and Content Uniformity Assessment: A Case Study
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Contributing OfficeCenter for Drug Evaluation and Research
Abstract
For solid oral dosage forms, blend and content uniformity (BU/CU) are critical for ensuring minimal dose-to-dose variability. Per 21CFR211.110, current good manufacturing practice for finished dosage form requires adequate mixing to assure uniformity and homogeneity. In an effort to streamline regulatory assessment, the Office of Pharmaceutical Manufacturing Assessment (OPMA) developed several review guides pertaining to BU/CU assessment of solid oral dosage forms between 2020 and 2022. However, when it comes to applying these general frameworks to actual cases, OPMA assessors frequently face the challenge of making an appropriate regulatory decision based on a complexity of impacting factors. Aiming to disseminate these complex factors affecting BU/CU, we present a recent case study to demonstrate our regulatory approach in assuring BU/CU for an immediate release tablet drug product. Our assessment incorporated various relevant factors, such as the initial risk scenario, available data, sampling plan, statistical methods, and commitments for validation and commercial batches. In addition, any BU/CU issues for similar products discovered during facility inspection were also taken into consideration. This case study adds to a more detailed interpretation of the current BU/CU assessment directives outlined in the review guides, which should enhance our regulatory decision-making when tackling cases of similar nature.
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