AaMEDI offers Responsible Person RP FvP / QP services
Every Pharma company in Switzerland with Swissmedic licenses must employ a Responsible Person RP (Responsible Person, Fachtechnisch verantwortliche Person, FvP). The RP must follow in his tasks EU-GDP Guidelines as well as all Swissmedic regulations. The qualification of the RP is defined in AMBV.
RP FvP QP tasks and responsibilities
- Continuously quality management meetings
- Creating and maintaining GDP Quality system
- Handling of GDP Documentation and records
- Creating, maintaining, training, releasing and archiving of SOPs
- Creating and signing Technical quality agreements
- Checking commercial agreements
- Creating and maintaining Job descriptions
- Monitoring GDP transports / temperature releasing
- Performing Supplier audits and qualifications
- Performing Customer qualifications9
- Swissmedic Inspections, Contact person towards authorities
- Preparing license applications to Swissmedic
- Performing internal and external audits
- Handling of Complaints, Deviations and Return of Goods
- Performing Risk and Recall Management
- Handling of all Wholesale Operations
- Performing CAPA, Falsified medicines
- Management Reviews