AaMEDI offers Quality Assurance and Regulatory Sevices for Pharma companies
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.
- 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
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
- Auditing services, site visits
- Technical Quality Agreements
- Swissmedic License Applications and all other Swissmedic issues
Quality Management System is needed for all Pharma companies. AaMEDI offers whole Quality Management Systems (QMS) based on GDP/GMP and Swissmedic requirements for all Pharma customers.
- Quality Manual Handbook
- Standard Operation Procedures
- Swissmedic Licenses, correspondence with Swissmedic
- Swissmedic inspection documentation
- Company profile and strategy
- Company's operating model
- Organizational Chart and Personnel
- Agreements with Partners
- Logistic strategy, supply chain
- Records and documents
