Qualified Person Switzerland

According to Swiss pharmaceutical law, the Qualified Person (or FvP - Fachtechnisch verantwortliche Person) is responsible for compliance with pharmaceutical regulations (GxP compliance) in manufacturing, wholesale, import and export. They are therefore responsible for the technical supervision of pharmaceutical manufacturing operations. In addition, the Qualified Person is also responsible for seamless documentation and compliance with legal regulations. They are the decisive interface between the company and the authorities. In exercising its function, the Qualified Person must be independent.

• Performing all tasks arising from Article 5 of the AMBV
• Ensuring the required quality of the pharmaceutical products manufactured
• Interface with the regulatory authorities (e.g. Swissmedic)
• Market release of finished pharmaceutical products and active pharmaceutical ingredients
• Technical release or decision on non-release of product batches
• Preparation of audits and inspections
• Supplier qualification Preparation and implementation of audits and inspections
• Supplier qualification
• Examination of medicinal product law requirements for the import and export of starting materials, packaging materials and medicinal products
• Introduction and maintenance of the quality management system
• Examination and approval of GxP-relevant SOPs
• Reviews of critical deviations and OOS
• Handling of complaints and recalls