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Our quality management penetrates all levels and services of Minerva Analytix GmbH from the quality control of LOT release test to production-accompanying in-process controls. As a service provider for quality testing, we naturally comply with all legal requirements, standards and other regulations in the field of quality control and assurance. We receive important input for the constant improvement of our quality standards from a large number of customer audits per year. Competence and know-how of our team guarantee implementation of our quality standards in all our processes.
Good Manufacturing Practice and thus the requirements of the German Drug Law and the EU-GMP Guide to Good Manufacturing Practices are being implemented in all areas of Minerva Analytix GmbH, in which pharmaceuticals, starting materials and packaging materials are tested. As part of our 2017 inspection we also implemented as far as possible all the requirements of cGMP and this has successfully been confirmed by several customer audits.
Minerva Analytix takes part in proficiency tests in the areas of nucleic acid analysis and endotoxins. We are happy to offer our customers the certificates as part of audits on the following topics: human viruses (HAV, HBV, HCV, HIV-1, HIV-2 and PB19), mycoplasma (nucleic acid analysis) and endotoxins (using chromogenic LAL).
Minerva Analytix offers GMP-compliant and rapid biosafety testing using state-of-the-art molecular biology methods to prevent and contain biological contamination in your applications.
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