Quality

Quality is always our highest priority. That is why we have chosen to operate from an ICHQ7 guideline based quality system. This ensures that all our processes, products and methods comply with the highest GMP standards that have been established for pharmaceutical ingredients. The realization of our new QA/QC building in 2005 made it possible to fully implement our ICHQ7 quality system.

The quality of our products and processes is assured by strictly following all procedures in our ICHQ7 guideline based quality system. All our processes and analytical methods are designed for and dedicated to the production of PURASORB products and are validated accordingly.

For each batch a certificate of analysis is provided, showing the analytical data determined in our quality control laboratory. Additional analytical data can be made available upon request.

We are ISO 9001: 2000 and ISO 14001: 2004 certified and all our polymers and monomers are covered with a Device Master File (MAF 1346) and a Drug Master File (DMF 21817) filed at the FDA. Our customers audit our facilities on a regular basis.