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Innovation and Continuous Improvement in Pharmaceutical Manufacturing Pharmaceutical CGMPs for the 21 st Century The PAT Team and Manufacturing Science Working Group Report: A Summary of Learning, Contributions and Proposed Next Steps for Moving towards t

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Abstract

The health of our citizens depends on the availability of safe, effective and affordable medicines. In the future, pharmaceutical manufacturing will need to employ innovation, cutting edge scientific and engineering knowledge, and the best principles of quality management to respond to the challenges of new discoveries (e.g., complex drug delivery systems and nanotechnology) and ways of doing business such as individualized therapies or genetically tailored treatments. "Pharmaceutical cGMPs for the 21 st Century " was intended to enhance and modernize the regulation of pharmaceutical manufacturing and product quality. This report provides an overview of the PAT Team's and Manufacturing Science Working Group's collaborative efforts, accomplishments, and points to consider as the initiative moves into its next phase (implementation and continuous improvement). The FDA Science Board and the Advisory Committee for Pharmaceutical Science (ACPS) discussions provided information on the current state of pharmaceutical manufacturing, challenges faced, and opportunities for improvement. These discussions are the primary basis of this report

Year: 2009
OAI identifier: oai:CiteSeerX.psu:10.1.1.135.8306
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