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Stephen Tindal

 

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Continuous manufacturing: regulatory and quality assurance challenges

22 August 2017 | By , ,

During 2002, the United States Food and Drug Administration (FDA) requested rationalisation and modernisation of the manufacturing base for pharmaceutical production. This was in the hope that modernising the supply chain would enhance the robustness of manufacturing processes, thereby reducing product failures and, importantly, significantly enhancing product quality.1 The FDA’s…