News about GMP/cGMP

06.11.2020

Swissmedic: Adaptions to inspection routine due to Covid-19

Given the changed situation regarding COVID-19 and the differing measures introduced by the various cantons in Switzerland, Swissmedic has decided to adapt the way inspections in the healthcare field are carried out. As of 3 November 2020, inspections will only be performed after prior clarification of possible COVID-19-related capacity problems.

The inspections may be carried out while observing the recommended 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 inspections are carried out on site, participants must organise the necessary safety precautions for the inspections (meeting rooms with sufficient space, restricted participant numbers, provision of electronic resources such as projectors for document assessment, plus face masks, sanitisers, etc.). 

Swissmedic provides a questionnaire for download, which must be completed by the inspected company prior to the inspection. Therein the protective measures are recorded and confirmed.


Source:

Swissmedic: News and Updates 



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