Covid-19: Swissmedic adapts Inspections
Recommendation
11/12 February 2025
Heidelberg, Germany
Medicinal Products/Drugs meet Medical Devices
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
Related GMP News
18.12.2024Swissmedic Position Paper on Clinical Trials
05.12.2024ICH E6(R3) Annex 2 Draft Guideline Released
05.12.2024ICH M15 Draft Guideline on Model-Informed Drug Development
07.11.2024Interim-Report on EMA's Clinical Study Data Proof-of-Concept Pilot
07.11.2024FDA Issues Guidances to Support Clinical Trial Innovation
17.10.2024FDA's final Q&A Document on Electronic Systems & Data in Clinical Trials