Description
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Raw materials are a
fundamental element in the manufacturing of biopharmaceuticals that can
impact the performance of the manufacturing process and resulting product
quality. To ensure consistent production of high-quality medicines for
patients, it is necessary
to have a holistic raw material control strategy that includes both
scientific and risk-based considerations along with in-depth knowledge of the
relationship between raw material attributes and critical to quality
attributes.
This presentation will focus on key elements of our raw material control strategy. One of these elements is a framework for identifying important material attributes necessary to define fit-for-purpose raw material specifications. With advances in digital integration of data, it is now possible to use data analytics for trending raw material performance as a means of monitoring and predicting variation in these important attributes to prevent impact on process performance and product quality. A case study will be presented to highlight how these tools are used to enhance our understanding of the relationship between raw material attributes and product quality attributes to help define well-informed control strategies. Learning Objectives:
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Contributors
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Susan Burke, Ph.D.