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Application of this innovative approach will quickly orient regulators to the content of Module 3, “present product quality benefit-risk considerations, summarize the pharmaceutical development, present an overall understanding of the product quality,” 1 and facilitate continuous improvement.
Application of this innovative approach will quickly orient regulators to the content of Module 3, “present product quality benefit-risk considerations, summarize the pharmaceutical development, present an overall understanding of the product quality,” 1 and facilitate continuous improvement.
In addition, single-use technologies have been increasingly employed throughout manufacturing because of the advantages they offer, including reductions in cost, manufacturing footprint, contamination risk, and processing times (Figure 1). There is undoubtedly a need for improved supply chain flexibility to address shortages.
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