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清洁验证完成之后,共用设施里的设备中更换产品时是否需要进行分析检测?

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kk444555 一阶会员 用户来自于: 广东省深圳市
2023-10-17 22:47

Analytical testing is expected at each changeover unless justified otherwise via a robust, documented Quality Risk Management (QRM) process. The QRM process should consider, at a minimum, each of the following:
在每次更换产品时均应进行分析检测,通过稳健的书面质量风险管理(QRM)流程进行论证者除外。QRM应至少考虑以下内容:
 the repeatability of the cleaning process (manual cleaning is generally less repeatable than automated cleaning);
清洁工艺的可重复性(人工清洁通常比自动清洁可重复性更差)
the hazard posed by the product;
产品危害性
whether visual inspection can be relied upon to determine the cleanliness of the equipment at the residue limit justified by the HBEL.
是否可依赖目视检查来确定HBEL所论证的残留水平下的设备清洁程度

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发布时间
2023-10-17 22:47
更新时间
2023-10-17 22:47
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