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Minaris - Quality Control and Quality Assurance Services
Quality control and quality assurance are essential elements of Minaris Regenerative Medicine’s production, ensuring the quality and consistency of every batch of product. Each step of the manufacturing process is strictly controlled and carefully documented. Through external GMP/GLP audits performed by our trained personnel, we ensure that all external partners fully comply with regulatory standards and with our own stringent requirements.
The quality-by-design concept and the risk-based approach embedded in all stages of Minaris Regenerative Medicine’s pharmaceutical development minimize the risk of potential setbacks.
The combination of a full range of quality management components with our quality control procedures enables tight control of the manufacturing process, full traceability throughout the production procedure and the highest level of GMP compliance. In this way, Minaris Regenerative Medicine is able to provide a robust manufacturing process and to guarantee reliable excellence in all our cell products and highly consistent batch-to-batch quality.
Within our European region (Minaris Regenerative Medicine GmbH), experienced Qualified Persons (QP) are responsible for the final product certification, according to all current EU Directives and ATMP-guidelines.