Quality Assurance

Quality Concept

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 (GMP)

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.

Permits and qualifications

Certificate of GMP compliance
Permission to process samples of security level BSL2/3 ** (IfSG)
Genetic Engineering allowance (Level 2) according to German Gen Technology Law (GenTG)
Project manager (GenTSV)
Biological safety officer according to German Biosafety Law (BioStoffV)