Qualified Person Switzerland

According to Swiss pharmaceutical law, the Qualified Person for Switzerland is responsible for compliance with pharmaceutical regulations (GxP Compliance) in manufacturing, wholesale, import and export. He or she is thus responsible for the technical supervision of the pharmaceutical manufacturing operation. In addition, the Qualified Person is also responsible for complete documentation and compliance with legal regulations. It is the decisive interface between the company and the authorities. In the exercise of its function, the Qualified Person must be independent.

Natalie Thurner
Qualified Person (FvP) for Switzerland
With an experienced Qualified Person for Switzerland, we support you in the production and distribution of pharmaceuticals in Switzerland. We act as your interface to all swiss authorities and keep your back free for the day-to-day business.

Our FvP services at a glance:

  • Performing all tasks arising from Article 5 of the AMBV.
  • Ensuring the required quality of the manufactured medicinal products.
  • Interface to the regulatory authorities (e.g. Swissmedic).
  • Market release of pharmaceutical end products and active ingredients.
  • Technical release or decision on non-release of product batches Preparation of audits and inspections.
  • Examination of legal requirements for the import and export of starting materials, packaging materials and medicinal products.
  • Quality control.
  • Quality assurance.
  • Review and approval of GxP relevant SOPs.
  • Reviews of critical deviations and OOS.
  • Handling of complaints and recalls.

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