In light of the current situation regarding the COVID-19 pandemic and the precautionary measures stipulated by the federal and cantonal governments to combat the pandemic, Swissmedic hereby specifies the conditions under which inspections are to be carried out on site. As hitherto, inspections in the healthcare field will only be performed after prior clarification of possible COVID-19-related capacity problems.
Consideration of the current pandemic situation
10.02.2021
The inspections may be carried out with due consideration of the risk, i.e. while observing the necessary protective measures – either (partly) by means of remote assessments or at a later point in time. Safety assessments – whether non-routine and scheduled and “for cause”, or routine and scheduled but process-specific – will generally take place on site.
If an on-site inspection has to be carried out, or if this has been agreed, Swissmedic and the company concerned must organise the necessary safety precautions for the inspection (meeting rooms with sufficient space, restricted participant numbers, provision of electronic resources such as projectors for document assessment, plus face masks, sanitisers, etc.) The precautions must ensure compliance with all the relevant cantonal and national requirements. Alternatives to an on-site inspection (e.g. remote assessment or deferral) must always be considered and, where appropriate, given precedence.