News about GMP/cGMP

07.09.2020

Swissmedic: On-site inspections on a regular basis again

The Swiss Agency for Therapeutic Products, Swissmedic, will, according to an announcement made on 1 September 2020, carry out regular GMP and GDP inspections on site again with immediate effect. Protective measures such as distance and hygiene rules must continue to be followed and infections must be traced.

The decision follows the gradual relaxation of the COVID-19 measures.   

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.   

The inspected company is obliged to take the necessary precautions to carry out the inspection safely. Meeting rooms must have sufficient space so that distance can be kept. If this is temporarily not possible, face masks must be worn. Where possible, electronic resources are to be used.  

Inspections are carried out both by Swissmedic and by four regional offices.  


Source:   

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



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