Every Pharma company in Switzerland with Swissmedic licenses must employ a Responsible Person RP (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.
- Continuously quality management meetings
- Creating and maintaining EU-GDP Quality system
- Handling of GDP Documentation
- Creating, maintaining, training, releasing and archiving of SOPs
- Creating and signing Technical quality agreements
- Checking commercial agreements
- Creating and maintaining Job descriptions
- GDP transport / temperature releasing
- Performing Supplier audits and qualifications
- Customer qualifications, Change control
- Swissmedic Inspections, contactperson towards Swissmedic
- Perform Swissmedic license applications
- Internal and external audits
- Handling of Complaints, Deviations and Return of Goods
- Risk and Recall Management
- Handling of all Wholesale Operations
- CAPA, Falsified medicines
- Management Reviews
AaMEDI provides following QA services:
- Setup of quality system and implementation
- Maintain the quality system
- Responsible Person (RP) / FvP
- RP deputy services / FvP Stellvertreter
- Qualified Person (QP) services
- Support in GDP/GVP/GMP - related issues
- Pharmacovigilance Responsibility
- Auditing services, site visits
- Technical Quality Agreements
- Swissmedic License Applications
- Swissmedic issues
