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Swissmedic: GMP/GDP inspections accreditation for ATMPs

On 9 August 2023, Swissmedic announced its accreditation for GMP/GDP inspections in the field of ATMPs (Advanced Therapy Medicinal Products). Previously, the authority's competence confirmation was limited to medicinal products.

The Swiss Accreditation Service SAS evaluates and accredits different types of conformity assessment bodies based on the respective corresponding standard. It is a legal requirement in Switzerland that inspection bodies must hold an ISO 17020 accreditation. The aim is to ensure that inspections are carried out according to specified standards and that inspectors meet the necessary professional competence.

By receiving the independent confirmation of competence from SAS, the Swiss agency is first in the field, as no other authority has accreditation for GMP/GDP inspections for ATMPs.


Source:

Swissmedic: Accreditation for GMP/GDP inspections in the field of ATMPs

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