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.
Once the health-based assessment has been completed and the HBEL ed, 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.
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 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.
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.
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.
Additional observation of working practices, investigation and analysis may be required to provide full practical confidence in the effectiveness of controls.
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.
