Current Good Manufacturing Practice
Customer satisfaction is the measure of success for Boehringer Ingelheim and our customers expect nothing less than the highest product quality. Our standards are based on the World Health Organization's principles of current Good Manufacturing Practice (cGMP).
Highest quality from start to finish
All our substances and products are carefully tested prior to further processing. Testing is performed according to standard pharmacopoeias, state-of-the-art methods developed by Boehringer Ingelheim, due to customer specifications. The continuous harmonisation of product and quality on behalf of the customer is all in a day's work for us. The certificate of analysis, issued for every batch produced, vouches for the quality delivered to all our customers.
Good partnership relations
Customers develop active ingredients and medicines in close cooperation with us. Good partnership relations and mutual trust are thus fundamental elements of our joint success. Personal integrity, competence and a sensitive touch are essential qualities for our project managers. Sophisticated security arrangements and Chinese walls established throughout the Boehringer Ingelheim group guarantee that our customers´ intellectual property is totally protected.
cGMP standards
We use the cGMP system for product-focused quality management in the manufacture of active pharmaceutical ingredients (APIs). All our API production sites are FDA-inspected.
EHS requirements
All plant operations meet all relevant environmental, health and safety requirements (EHS). Our production sites in France, Italy, Spain and United States are fully DIN ISO certified. The RESOMER® unit in Germany is DIN ISO EN 9001 certified, with additional application of IPEG-GMP guidelines.
Quality regulation links
- Current Good Manufacturing Practices (cGMP)
- Deutsches Institut für Normung - DIN (German Institute for Standardization)
- Environment, Health and Safety Online (EHS)
- Food and Drug Administration (FDA)
Our regulatory philosophy
Learn more about our regulatory services.
