Quality Management

Medicine to feel well again
Montavit – Quality Management

Our quality system is rated top standard by frequent audits of leading multinational pharmaceutical companies which put us on their list of preferred suppliers. Quality Management is a core responsibility of our management system. Its objective is to secure and to raise the quality, effectiveness and efficiency of our work and our productivity. By quality management, we mean all measures which lead to heighten the quality of our products, our process or our services.

EU Guidelines on Good Manufacturing Practice, Appendix 15
“Process validation is the documented evidence that the process, operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its predetermined specifications and quality attributes.”
This is why we see quality management and preventive quality assurance as the foundation underpinning both our company and the ongoing training of our staff and their working life. Strict compliance with cGMP (Good Manufacturing Practice) rules is naturally at the heart of our everyday activities.

cGMP (Medicinal products)
ISO 13485:2007
Annex II, Section 3, Directive 93/42/EEC (Medical devices)