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Outsourced activities MVS Pharma: Under the EU Good Distribution Practice (GDP) Guidelines, outsourced activities represent a critical area of regulatory focus. While certain operational tasks may be performed by external service providers, responsibility for GDP compliance always remains with the wholesale distributor. EU GDP, therefore, requires companies to exercise full oversight, qualification, and control over all outsourced activities. At MVS Pharma GmbH, outsourcing is managed through a structured, risk-based system that ensures external partners operate to the same high standards as internal processes.
EU GDP Expectations for Outsourced Activities
EU GDP Chapter 7 requires that any activity impacting the quality, integrity, or security of medicinal products is subject to formal control when outsourced. Key expectations include:
- Qualification and approval of service providers
- Written quality or service agreements
- Clear definition of roles and responsibilities
- Ongoing performance monitoring
- Documentation and traceability
- Final accountability is retained by the Responsible Person (RP)
Outsourcing an activity must never mean outsourcing responsibility.
Outsourced Activities MVS Pharma GmbH
- Transportation and Logistics Services
Transportation is one of the most critical outsourced activities under EU GDP, as it directly affects product integrity. MVS Pharma GmbH outsources transportation activities to GO Express, a qualified service provider selected through a formal approval process.
Before engagement, the transport provider is evaluated for:
- GDP compliance and operational capability
- ability to maintain required transport conditions
- handling procedures and incident management
- documentation and traceability practices
Transport performance is monitored on an ongoing basis to ensure continued compliance.
- Outsourced Training Services
To ensure continuous competence and regulatory awareness, MVS Pharma uses qualified external training providers as part of its training strategy. These include ECA Academy, Berlin BioScience Academy, and Johner Institute GmbH.
External training providers are assessed based on:
- subject-matter expertise
- regulatory relevance
- training quality and credibility
- alignment with EU GDP expectations
Training outcomes are documented, reviewed, and integrated into MVS Pharma’s Digital Quality Management System.
- Calibration, Maintenance, and Technical Services
Critical equipment calibration and maintenance activities are outsourced to qualified service providers. These activities are essential to ensuring accurate environmental monitoring and reliable infrastructure performance.
Service providers are approved through:
- qualification and capability assessment
- defined service scope
- documented calibration standards
- traceable certification and reporting
All calibration and maintenance records are reviewed and retained under the Digital QMS.
- Pest Control and Facility Support Services
Pest control services are outsourced to specialized providers operating under controlled agreements. Activities are performed according to defined schedules and documented procedures to maintain a hygienic and GDP-compliant warehouse environment.
Service performance is periodically reviewed to ensure effectiveness and compliance.
- IT and Data Support Services
Where IT or data-related services are outsourced (e.g., system support or backups), MVS Pharma ensures that data integrity, confidentiality, and availability are protected. Controls are implemented to prevent unauthorized access or data loss and to support business continuity.
Qualification and Oversight of Outsourced Partners
- Formal Approval and Quality Agreements
All outsourced activities are governed by written quality or service agreements. These agreements clearly define:
- scope of services
- GDP responsibilities
- documentation requirements
- deviation and escalation procedures
- audit rights
Only approved service providers are permitted to perform GDP-relevant activities.
- Performance Monitoring and Review
Outsourced activities are subject to ongoing oversight through:
- performance reviews
- deviation and incident trending
- service feedback
- audit outcomes
Any identified deficiencies are addressed through corrective and preventive actions (CAPAs).
Responsible Person Oversight
- Final Accountability
The Responsible Person (RP) retains ultimate responsibility for all outsourced activities affecting GDP compliance. The RP ensures that outsourced services are adequately controlled, reviewed, and documented, and that regulatory obligations are consistently met.
Conclusion
MVS Pharma GmbH is committed to maintaining full control and accountability over all outsourced activities in accordance with EU GDP requirements. Through careful provider selection, formal agreements, continuous oversight, and strong Responsible Person involvement, MVS ensures that outsourced services support – rather than compromise – the integrity, quality, and safety of medicinal products.
