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The future direction of ASTM E55 Committee on manufacture of pharmaceutical products

publication date: Nov 23, 2007
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ASTM Committee E55 formed in April of 2003 as a result of FDA’s GMPs for the 21st Century Initiative and the subsequent Guidance, “PAT – a framework for innovative pharmaceutical manufacturing and quality assurance.” Focusing on process understanding and flexible manufacturing, FDA encouraged the pharmaceutical industry to utilise the consensus standards approach to enable implementation of PAT principles into their manufacturing processes.



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