We only deliver services or products which are in compliance with our strict quality standards. All services are performed following or exceeding all current rules and regulations for the protection of health, safety and environment.

For our pharmaceutical products, we have the following quality policy in place:  

ChemCon GmbH commits that all API batches with a Certificate of Compliance issued and produced at the ChemCon facilities in Germany are manufactured in accordance with current Good Manufacturing Practices as set forth in 21 CFR Parts 210, 211 and ICH Q7A.

For details about our Quality Assurance Management, please refer to the article “Drug Quality Assurance: Systems at ChemCon” on this website.

 

We had the following regulatory audits:

• July 2000: ChemCon passed the first audit by the Food and Drug Administration (FDA) without any deficiency (No 483 issued). This audit referred to the fastest approval of a cytostatic drug in FDA history.

• July 2003: Regierungspräsidium Freiburg according to German Biological Regulations. 

• January 2006: Regierungspräsidium Tübingen according to German Biological Regulations.

• January 2006: Regierungspräsidium Tübingen according to the approval of the Quality Control Department to release final dosage forms.

 

Customer Audits

We successfully passed over 25 customer audits. Included are audits by several of the TOP 10 pharmaceuticals companies.

Internal Audits

All our processes, facilities, equipment and SOPs are being regularly audited by our Quality Assurance.