Ensuring pharmaceutical quality begins with in-depth understanding of process/platform capabilities, which is informed by knowledge gained through product and process development, subject-matter expertise, and lessons learned from experience. And all outside factors that can affect manufacturing outcomes must be taken into consideration. Extra vigilance is necessary for understanding potential sources of variation and maintaining robust control strategies to ensure process consistency — and ultimately product quality for patients. Biomanufacturing unit operations require multiple raw materials that must be documented as fit for their intended use. Coming from multifaceted supply chains with many starting materials and subsuppliers, bioprocess raw materials present a challenging source of variation. In this eBook, authors from Amgen describe the elements of a strategy for raw material controls using data analytics to enhance understanding for predict-and-plan capabilities.
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