Qualified Person
The holder or applicant of an establishment licence is responsible to have a suitable RP available.
The RP must be able to execute his/her responsibility, understand the Swiss GMP/GDP requirements and meet regulatory compliance.
The direct supervision of the company by the RP to ensure compliance with the legal requirements must be guaranteed at any time.
Services:
• Performing all tasks arising from article 4, article 5, article 7, article 13, article 15, article 16, article 17, article 22, article 23, article 25, article 26 of the MPLO.
• 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.
• Review and approval of GxP relevant SOPs.
• Reviews of critical deviations and OOS.
• Handling of complaints and recalls.
• QP Deputy.
• Due Diligence Processes and Reports.
• Management of the electronic portals of Swissmedic.