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Almac receives US FDA inspection approval for its analytical facilities at its Craigavon HQ in Northern Ireland

机译:Almac的北爱尔兰Craigavon HQ分析设施获得美国FDA检查批准

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摘要

Following on from successful MHRA audits in 2011, Almac's Sciences Business Unit has completed a successful inspection of its analytical facilities at its Craigavon Headquarters, Northern Ireland from the US Food and Drug Administration (FDA). The inspection of the control testing laboratory was in support of pre-approval inspections for products for which Almac Sciences are named as the contract test laboratory. The 3-day inspection covered the Quality and Laboratory Control systems and included tours of all test laboratories and specialist analytical facilities, including mass spectroscopy laboratories.
机译:继2011年成功进行MHRA审核之后,Almac科学业务部已成功地通过美国食品和药物管理局(FDA)对位于北爱尔兰Craigavon总部的分析设施进行了检查。控制测试实验室的检查支持对被Almac Sciences命名为合同测试实验室的产品的批准前检查。为期三天的检查涵盖了质量和实验室控制系统,并参观了所有测试实验室和包括质谱实验室在内的专业分析设施。

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