1 回答
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
