Covid-19: Swissmedic adapts Inspections

Recommendation

13/14 December 2023
Berlin, Germany

Root Cause Analysis
A CAPA Workshop on Successful Failure Investigation

Owing to the new situation regarding the COVID-19 pandemic and the differing measures introduced by the various cantons, Swissmedic has decided to adapt the way it carries out inspections. Inspections in the healthcare field 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.).

Source: Swissmedic