欧盟gmp中英文对照.ppt

Checks should be made to ensure that any electronic code readers, label counters or similar devices are operating correctly. 为确保电子条码识读器、标签计数器或相似仪器的正确操作，要进行必要的检查 Printed and embossed information on packaging materials should be distinct and resistant to fading or erasing. 包装材料上的印刷和压印信息应清楚，不退色，不易擦去 * Packaging Operations包装操作 On-line control of the product during packaging should include at least checking the following: 包装过程中，对产品的在线控制检查应至少包括以下方面： general appearance of the packages; 包装的外观 whether the packages are complete; 包装是否完整 whether the correct products and packaging materials are used; 是否使用了正确的产品和包装材料 whether any over-printing is correct; 打印是否正确 correct functioning of line monitors. 在线监测的正确功能 Samples taken away from the packaging line should not be returned. 不应返还从包装线取走的样品 * Packaging Operations包装操作 Products which have been involved in an unusual event should only be reintroduced into the process after special inspection, investigation and approval by authorised personnel. Detailed record should be kept of this operation. 涉及不正常事件的产品，要经过特定的检查、调查并被有资质人员批准后，才能再次使用。该过程的详细记录应保留。 Any significant or unusual discrepancy observed during reconciliation of the amount of bulk product and printed packaging materials and the number of units produced should be investigated and satisfactorily accounted for before release. 在核对待包装产品和印刷包材的数量及成品的数量时，如发现明显的或不正常的偏差，应对其进行调查。只有得到满意的答复后，该产品才能放行。 * Packaging Operations包装操作 Upon completion of a packaging operation, any unused batch-coded packaging materials should be destroyed and the destruction recorded. A documented procedure should be followed if uncoded printed materials are returned to stock. 包装操作完成后，所有没有用过的、印有批号的包装材料都应被销毁并且记录。如果把没有打印批号的印刷材料退回仓库，应按照书面的规程进行。 * Packaging Operations包装操作 Finished Product成品 Finished products should be held in quarantine until their final release under conditions established by the manufacturer. 成品应处于待检状态，直至它们满足了生产厂家的标准而批准放行 After release, finished p