Although the EMA guideline (EMA/CHMP/CVMP/SWP/169430/2012) may be used to justify cleaning limits (as per Introduction paragraph 3), it is not intended to be used to set cleaning limits at the level of the calculated HBEL.
尽管EMA指南（EMA/CHMP/CVMP/SWP/169430/2012）可以用于论证清洁限度（第3段介绍），但该指南并不是用来设立计算出的HBEL水平的清洁限度的。
For existing products, manufacturer’s historically used cleaning limits should be retained and can be considered alert limits provided that when taking cleaning process capability into account, they provide sufficient assurance that excursions above the HBEL will be prevented. A similar process should be adopted when establishing cleaning alert levels for products introduced into a facility for the first-time.
对于现有产品，生产商历史上所用清洁限度应保留，如果考虑清洁工艺能力，历史清洁限可以提供足够的保障防止残留超出PDE值，则可用该历史清洁值作为警戒限。
Results above the alert cleaning limit should trigger an investigation and, where appropriate, corrective action to bring the cleaning process performance within the alert cleaning limits. Repeated excursions above the alert cleaning limit will not be considered acceptable where these indicate that the cleaning method is not in control. Recognised appropriate statistical methods may be used to determine whether the cleaning process is in control or not.
超出警戒清洁限度的结果应启动调查，适当时应采取纠正措施将对清洁工艺性能控制在警戒清洁限内。反复超出警戒清洁限是不能接受的，这显示清洁方法可能已失控。公认的恰当的统计方法可以用于确定清洁工艺是否受控。