ChemCon´s commitment to Quality
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.
ChemCon Inspection history:- 4x by the German / European health authorities
- 15x by health, safety and environmental agencies
- more than 80x by customers or their consultants
- ChemCon also is an ISO 9001:2008 certified company
Exemplary track record of audits from both German and US authorities:- July 2000: ChemCon passed the first audit by the US 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: The Regierungspraesidium Freiburg conducted an audit according to German Biological Regulations.
- January 2006: The Regierungspraesidium Tuebingen as well audited according to German Biological Regulations.
- January 2006: The Regierungspraesidium Tuebingen approved our Quality Control Department to release final dosage forms.
- December 2007: ChemCon was again successfully inspected by the FDA and the full cGMP compliance of our manufacturing site was confirmed.
- July 2008: The Regierungspraesidium Tuebingen conducted a successful audit after which ChemCon is an approved API manufacturer according to German law
- December 2009: ChemCon and ChemCon America achieved ISO 9001:2008 certification. The regarding two-day audit was performed by two auditors of DEKRA Certification GmbH. They certified us commitment to our elaborated quality management system and its well structured processes.
- July 2011: FDA inspection went exceptionally well; no written citation
- September 2011: GMP certification for manufacture of three API by RPT
- Nov. 2011: Successful Inspection by Auditor DEKRA acc. to DIN EN ISO 9001:2008 (2. surveillance audit)
Customer Audits:
Our customers regularly visit us to inspect ChemCon’s quality assurance systems. We successfully passed over 80 customer audits. Included are audits by several of the top 10 pharmaceuticals companies worldwide.
Internal Audits:
All our processes, facilities, equipment and SOPs are regularly audited by our Quality Assurance.
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