The role of HBELs in determining cleaning limits is explained in Q&A 6. However, the purpose of generating HBELs goes beyond justification of cleaning limits.
问答6中解释了HBEL在确定清洁限度中的作用。但是，计算HBEL的目的远不止用于清洁限度论证。
Once the health-based assessment has been completed and the HBEL confirmed, these data should be used via a Quality Risk Management process to determine what controls need to be put in place and to assess if existing organisational and technical control measures are adequate or if they need to be supplemented. This Quality Risk Management process should be carried out prospectively in the case of new equipment/facility to determine what control measures are required.
在基于健康的评估完成并确认了PDE之后，这些数据应通过质量风险管理流程（QRMP）使用这些数据来确定需要制订哪些控制，并评估现有组织和技术控制措施是否已足够，还是需要增补措施。对于新设备/设施，应提前执行QRM流程以确定需要哪些控制措施。
It is expected that for products which present a higher potential harm to patients/animals, more elaborate organisational and technical control measures will be required. Using a structured Quality Risk Management process, manufacturers should consider the risks of cross contamination down to the established level from the HBEL. During the QRM study manufacturers should consider how easily such a quantity of contamination could occur, without detection, at batch and unit dose level.
对于具有较大可能伤害患者/动物的药品，期望能制订有组织的技术控制措施。使用结构化QRM流程时，生产商应考虑将交叉污染的风险从HBEL降至建立的水平。在QRM研究中，生产商应考虑在批次和单位剂量水平此污染数量是否很容易发生而未被发现。
The level of detail in the QRM process should be commensurate with the potential harm as indicated by the HBEL and the suitability of control measures supported by practical and science-based evidence.
QRM流程的详细程度应与HBEL所显示的潜在危害，以及实际和科学证据所支持的控制措施的适当性相称。
Manufacturers should be mindful that cross contamination controls implemented previously may not adequately assure control of the cross-contamination risk in the context of the HBEL approach.
生产商应留意之前所实施的交叉污染控制可能并不够保证在HBEL方法中对交叉污染风险的控制。
Additional observation of working practices, investigation and analysis may be required to provide full practical confidence in the effectiveness of controls.
可能需要更多观察工作方法、进行调查和分析来为控制提供全面实操可信度。
Where control measures cannot adequately assure that the potential contamination is consistently controlled to a level below that of the HBEL then the products concerned should be manufactured in dedicated facilities.
如果控制措施不能充分保障潜在污染受到持续等同控制至一个低于HBEL的水平，则被关切的产品应在专用设施中生产。