Control Strategies for Drug Product Continuous Direct Compression-State of Control, Product Collection Strategies, and Startup/Shutdown Operations for the Production of Clinical Trial Materials and Commercial Products.

@article{Almaya2017ControlSF,
  title={Control Strategies for Drug Product Continuous Direct Compression-State of Control, Product Collection Strategies, and Startup/Shutdown Operations for the Production of Clinical Trial Materials and Commercial Products.},
  author={Ahmad Almaya and Lawrence De Belder and Robert Earl Meyer and Karthik Nagapudi and Hung-Ren Homer Lin and Ian M Leavesley and Jayanthy Jayanth and Gurjit Bajwa and James C Dinunzio and Anthony Tantuccio and Dan Blackwood and Admassu Alemayehu Abebe},
  journal={Journal of pharmaceutical sciences},
  year={2017},
  volume={106 4},
  pages={
          930-943
        }
}
Continuous manufacturing (CM) has emerged in the pharmaceutical industry as a paradigm shift with significant advantages related to cost, efficiency, flexibility, and higher assurance of quality. The inherent differences from batch processes justify examining the CM control strategy more holistically. This article describes the current thinking for the control and implementation of CM, using the example of a direct compression process and taking into consideration the ICH Q10 definition of… CONTINUE READING
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