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.
We have a 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
Customer Audits:
Our customers regularly visit us to inspect ChemCon’s quality assurance systems. We successfully passed over 40 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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