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Since 2016, drug approvals per clinical campaign have outpaced the average across all modalities, resulting in 11 FDA-approved therapies in that span. Cone-bottom reaction vessels can provide the turndown required to process a variety of scales and handle different reactions.
Examples include platforms as small as autonomous units placed within a facility and mobile production trailers for compounding to platforms as large as a prefabricated, self-contained GMP facility. FDA Official Warns Manufacturers of Common Problems Found in Aseptic Operations.” September 2022. 7 March 2023. Regulatory Focus.
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.
With shortages, regulatory complexity is compounded due to differences in submission and data requirements from various regulatory agencies. Although they have been historically overlooked as a key element, raw materials are a critical component at every stage of the drug manufacturing processes. Burke, PhD. 1 September 2022.
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