COVID-19: GMP/GDP inspections following the end of the extraordinary situation

Expansion of on-site inspections following the easing of COVID-19 measures

01.09.2020

Following the gradual relaxation of measures to combat the spread of the new coronavirus in Switzerland in summer 2020, Swissmedic has decided to resume regular on-site inspections, provided the necessary protective measures can be complied with and the inspection process is safe for everyone involved.

By agreement with the companies, regular on-site Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) inspections were resumed in July 2020 on condition that the applicable protective measures (distancing and hygiene rules, tracing of coronavirus infections) can be adhered to.

Before inspections are carried out on site, the companies are asked to complete a questionnaire to record and confirm the protective measures for inspections during COVID-19. Swissmedic or the regional Medicines Inspectorate will define the exact inspection process.

If inspections are carried out on site, the company being inspected must organise the necessary precautions for the inspection (meeting rooms with sufficient space, restricted number of participants, electronic resources, etc.). Face masks must be worn if, for short periods of time during an inspection, it is not possible to comply with social distancing rules.

The inspection work at manufacturing and wholesale companies is carried out not only by Swissmedic but also, to a significant degree, by four cantonal inspectorates (regional offices).

Related documents

Bestätigung der Umsetzung von Schutzmassnahmen für Inspektionen unter COVID-19 (Confirmation of implementation of protective measures for inspections during COVID-19)