Quality management

BOLDER Arzneimittel operates a quality management system that encompasses both the European Union's guidelines on good manufacturing practice (GMP) and the DIN EN ISO 9001 and DIN EN ISO 13485 standards.

Processes and product quality are continually validated and improved through internal audits or self-inspections as well as by regular audits by national and international customers and authorities. In this regard customer satisfaction is at the centre of all corporate decisions.

The qualified staff of all divisions of the company receive ongoing training. All premises and facilities are regulated and the manufacturing process and testing methods are validated.