Swissmedic gains accreditation for GMP/GDP inspections in the field of ATMPs


Swissmedic carries out inspections to verify compliance with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP). These quality standards are important guidelines in ensuring the quality of medicinal products. Inspection bodies that carry out these inspections in Switzerland must hold the legally prescribed ISO 17020 accreditation. In particular, this accreditation confirms the existence of a functioning quality management system and the expertise of the inspectors.

The Swissmedic inspectorate already holds this accreditation – which is issued by the Swiss Accreditation Service (SAS) and reviewed every one to two years as part of an audit – in the area of medicinal products. During the most recent audit, the SAS also examined an application from Swissmedic to extend the scope of its accreditation limited to medicinal products to include GMP/GDP inspections of ATMP products. The ATMP inspections are carried out under the functional management of the Inspectorate Unit and have been integrated in the Inspectorate Unit's QM system for many years.

After evaluating the audit, the SAS recently decided to grant Swissmedic an extension to its accreditation to include GMP/GDP inspections in the field of ATMPs. This makes Swissmedic the world’s first and only authority to gain this independent confirmation of competence in GMP/GDP inspections for ATMPs.