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ISO22716认证咨询|ISO22716认证辅导培训|控制偏差从过程到成品,一个环节也不能放松

2.13Control 控制


verification that acceptance criteria are met 确认可接受准则得到满足


2.14Deviation 偏差


internal organization and responsibilities relative to the authorization to deviate from specified requirements due to a planned or unplanned and, in any case, temporary situation concerning one or several activities covered by the Good Manufacturing Practices

由于计划的或非计划的临时情况,组织和职责偏离了 GMP 所覆盖的一个或多个活动的特定要求。


2.15finished product 成品


cosmetic product that has undergone all stages of production, including packaging in its final container, for shipment


化妆品产品经历了所有的生产阶段,包括在其最后的容器包装,出货。


2.16in-process control 过程控制


controls performed during production in order to monitor and, if appropriate, to adjust the process to ensure that the product meets the defined acceptance criteria

对生产过程进行监控,如果需要可对过程进行调整以确保产品达到可接受准则。


2.17internal audit 内审


systematic and independent examination made by competent personnel inside the company, the aim of which is to determine whether activities covered by these guidelines and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable for achieving objectives


由内部有能力的人员实施的系统和独立的检查,目的是为了确定活动是否覆盖了与指南和策划的相关结果,以及这些安排是否得到有效实施并适用于实现目标。


2.18major equipment 主要设备


equipment specified in production and laboratory documents which is considered essential to the process


在生产和实验室文件中详细说明的,被认为是对加工必不可少的设备

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