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      Chapter

      Process Analytical Technology and Validation
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      Chapter

      Process Analytical Technology and Validation

      DOI link for Process Analytical Technology and Validation

      Process Analytical Technology and Validation book

      Process Analytical Technology and Validation

      DOI link for Process Analytical Technology and Validation

      Process Analytical Technology and Validation book

      Edited ByJames P. Agalloco, Frederick J. Carleton
      BookValidation of Pharmaceutical Processes

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      Edition 3rd Edition
      First Published 2008
      Imprint CRC Press
      Pages 24
      eBook ISBN 9780429113963
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      ABSTRACT

      Conventional pharmaceutical manufacturing practices

      have low manufacturing efficiencies and capacity util-

      ization, high scrap and reject levels, and therefore a high

      cost of quality. PATis a toolkit used to increase operational

      efficiencies, capacity utilization and process under-

      standing, while decreasing operating expenses and

      ensuring that quality is built into the product. Multiple

      benefits associated with PAT implementation have been

      identified, but these benefits are not without drawbacks

      such as limited employee technical knowledge and sub-

      optimal return on investment. The benefits and challenges

      of PAT are reviewed in this chapter, together with a

      discussion of the conventional pharmaceutical manufac-

      turing paradigm, PAT principles and tools, PAT guidance

      development to date, and PAT validation approaches.

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