New Version of Swissmedic's Guidance on GMP Compliance Verification of Foreign Manufacturers

Swissmedic has published version 5.0 of its guidance document for verifying compliance with Good Manufacturing Practice (GMP) by foreign manufacturers. This version, which will come into force on May 1, 2025, introduces updates relevant to marketing authorization holders (MAHs) and Responsible Persons (RPs) in Switzerland.

Purpose of the document

The purpose of this guidance is to clarify the documents that must be submitted in connection with new applications for authorization or variations of medicinal products for human or veterinary use, in order to demonstrate that the MAH has verified the GMP compliance of foreign manufacturers of active substances or ready-to-use medicinal products.

Key highlights:

• Responsibility of the Responsible Person (RP): It is the responsibility of the RP to ensure that both ready-to-use medicines and active substances have been manufactured in accordance with GMP requirements.

• Verification of compliance: This must be based on GMP certificates, audit reports, inspection reports, and manufacturer documentation. This verification may be subject to inspection by Swissmedic at any time.

• Documentation requirements vary depending on the equivalence of the GMP control system in the manufacturer's country:

• Countries with systems recognized as equivalent to Switzerland: it is sufficient to present valid GMP certificates (less than 3 years old) or official documentation with proof of inspection.

  Countries without recognized equivalence: GMP certificates + up-to-date audit reports, including CAPA assessment and inspection history, are required.

• Applicable exceptions: exceptions are provided for atypical active ingredients (e.g., food or cosmetic use) and for veterinary medicines authorized by notification under Art. 39 TPLO.

• Requirements for audit reports: Swissmedic emphasizes that remote audits are not accepted and specifies the minimum mandatory content of reports, which must include detailed information on the quality system, facilities, production, quality control, and auditor qualifications.

• Accepted languages: Documents may be submitted in German, French, English, or Italian. Documents in other languages must be accompanied by a certified English translation.

This document is particularly relevant for Swiss AIM holders who subcontract manufacturing operations outside Switzerland, as they must ensure strict compliance with these requirements in their regulatory submissions.