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DRUG COMPANIES TAKE CONTROL

机译:药物公司控制

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摘要

The pharmaceutical industry, responding to a simultaneous push from the market and pull from regulators, is taking tentative first steps toward the state of the art in automated manufacturing control and analysis.rnThe steps are a response to investor calls for cost control and to a new program from the Food 8c Drug Administration that eases the regulatory burden of making changes to validated manufacturing systems. According to managers at both drug and control systems companies, these steps are taking the industry away from a labor- and paperwork-intensive production regime toward a more streamlined world in which data analysis and process development are integrated from drug discovery to product launch.
机译:制药行业在响应市场的同时推动和监管机构的拉动的情况下,正在朝着自动化制造控制和分析的最新状态迈出暂定的第一步。这些步骤是对投资者要求成本控制和新的要求的回应。食品8c药品管理局(Food 8c Drug Administration)的计划,减轻了对经验证的制造系统进行更改的监管负担。药品和控制系统公司的管理人员都认为,这些步骤使整个行业从劳动和文书工作密集的生产体制转移到一个更加精简的世界,在该世界中,数据分析和过程开发从药物开发到产品发布都集成在一起。

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