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Supplier qualification and outsourcing expectations are laid down in EU-Directive 2001/83/EC (article 8, article 46, article 46b), EU-GMP Guidelines (chapters 5, chapter 7, annex 16) and national legislations.
Outsourced activities must be controlled by the pharmaceutical manufacturers and marketing authorization holders. The activities go beyond performing audits and establishing audit reports. Supplier qualification must be part of the quality management system to ensure the quality of all materials and services used.
Supplier qualification is a risk assessment tool which requires a well-structured documentation system for ongoing supplier evaluation. Regular supplier assessment and re-qualification are required. The quality of the supplied goods or services as well as changes at the supplier must be considered for the assessment.
Supplier qualification assures that all materials and services meet the GMP requirements and your internal acceptance criteria. It mitigates potential risk and increases the supply chain transparency to provide a consistent quality of the product.
To assure proper supplier qualification and continuous oversight we at Alpinapharm assist you with the supplier qualification and management process as we:
- Gather all vendor information and enter all required data in your data management system.
- Evaluate essential information and perform risk assessment according to your internal requirements.
- Perform regular controls for a continuous evaluation.
- Follow up on activities (vendor related complaints, audit CAPAs, etc.) and prepare reports.