欧盟 GMP中英文对照课件.ppt

tests to include a condition or set of conditions encompassing upper and lower operating limits. 测试包括操作的上、下限 Although PQ is described as a separate activity, it may in some cases be appropriate to perform it in conjunction with OQ. 虽然对PQ作为一个单独的行动进行描述，但是，有些情况下，也可与OQ结合进行。 Performance Qualification性能确认 。 Manufacturing equipment should be designed so that it can be easily and thoroughly cleaned. It should be cleaned according to detailed and written procedures and stored only in a clean and dry condition. 生产设备的设计应使其易于全面清洗。设备的清洗应按照详细的、书面规程进行。清洗后的设备只能储存在干净及干燥的环境中。 Washing and cleaning equipment should be chosen and used in order not to be a source of contamination. 应注意洗涤、清洁设备的选择和使用方式，以避免这类设备成为污染源。 Equipment设备 。 Equipment should be installed in such a way as to prevent any risk of error or of contamination. 设备的安装应有利于防止差错或污染。 Production equipment should not present any hazard to the products. The parts of the production equipment that come into contact with the product must not be reactive, additive or absorptive to such an extent that it will affect the quality of the product and thus present any hazard. 生产设备不能给产品带来任何危害。与产品接触的设备部件不应与药品发生反应、不应吸附或向药品中释放物质而影响产品的质量并因此带来危害。 Equipment设备 。 Balances and measuring equipment of an appropriate range and precision should be available for production and control operations. 生产和控制操作应配有适当量程和精度的天平和测量仪器 Measuring, weighing, recording and control equipment should be calibrated and checked at defined intervals by appropriate methods. Adequate records of such tests should be maintained. 测量、称量、记录和控制设备应按照规定的时间间隔根据适当的方法进行校正和检查。这些测试的纪录应保留。 Equipment设备 。 Fixed pipework should be clearly labelled to indicate the contents and, where applicable, the direction of flow. 固定管道上应清楚地贴有标明管道内容物的标签，必要时，应标明流向。 Distilled, deionized and, where appropriate, other water pipes should be sanitised according to written procedures that detail the action limits for microbiological contamination and the measures to be taken. 蒸馏水