At MVS Pharma GmbH, every medicinal product and every partner we work with is carefully evaluated to ensure compliance with EU regulatory requirements, patient safety expectations, and the highest standards of pharmaceutical integrity.
Our Quality Check Process combines EU GDP-compliant due diligence, GMP-oriented supplier assessment, and risk-based decision making to build a secure and transparent global supply chain.
Before any raw material, component, or medicinal product is sourced, MVS Pharma follows a structured supplier qualification process in accordance with our internal SOPs and EU GDP principles.
We begin by clearly identifying the product-specific and regulatory requirements, including:
This ensures that only suppliers with the required technical capability and regulatory status are considered.
Potential suppliers undergo an in-depth evaluation, which includes:
Authorizations and certificates are cross-checked using official regulatory sources such as EudraGMDP or equivalent national databases.
We obtain and evaluate quality-relevant documents, such as:
Where necessary, MVS may request product samples for analytical or performance evaluation to ensure compatibility with our internal quality standards.
All collected information is assessed using a risk-based approach.
Factors such as product criticality, supplier track record, regulatory compliance history, and supply chain complexity are evaluated to determine whether the supplier is suitable for partnership.
The final qualification decision is made by the Responsible Person (RP) in collaboration with Quality Management and senior leadership. Only suppliers that fully meet our compliance, safety, and quality expectations are approved and added to the Approved Supplier List (ASL).
When selecting manufacturers for finished products, medical devices, or critical components, MVS applies the same rigorous process – enhanced with GMP-focused requirements.
We specify:
Each manufacturer is evaluated based on:
MVS performs on-site visits or virtual assessments (when appropriate) to verify:
This ensures transparency and first-hand verification of the manufacturer’s quality system.
Before cooperation begins, a formal Quality Agreement is established, defining quality responsibilities for:
Following the assessment, the RP and Quality Management approve the manufacturer.
Performance is continuously monitored through:
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