Quality management in our product business covers the entire product’s lifecycle from research and development to production and application. We strive to create a safe and healthy clinical environment and take the quality, safety and efficacy of the medical and pharmaceutical products that we develop and manufacture very seriously.
Our operations are subject to extensive governmental regulation in virtually every country in which we operate. To fulfill our commitment to product quality and safety while complying with the numerous relevant regulatory requirements, our processes are embedded in comprehensive quality management systems. As a result, all of our products and procedures comply with quality and safety standards from their development to market approval, manufacturing and use in clinics, through to training customers and dealing with complaints.
Another cornerstone of our commitment to product quality and safety is our Global Quality Policy, which was jointly developed and approved by Global Manufacturing, Quality & Supply (GMQS) and Global Research and Development (GRD). As a key component of our quality management system, the Global Quality Policy describes our overarching quality objectives and reflects our commitment to providing uncompromised product and service quality, while maintaining compliance with relevant regulations.
To produce safe products with a reliable quality, our plants are subjected to regular external quality audits and reviews in accordance with local requirements. In addition to audits carried out by notified bodies and authorities, including the U.S. Food and Drug Administration (FDA), the German Ministry of Health and other applicable national health authorities, our local sites are subject to management reviews and regular internal quality audits. Any cases of non-conformance detected as part of these quality audits are forwarded to the respective department to determine and implement appropriate corrective and preventive measures.