ChemCon only delivers services or products conforming to our strict quality standards. All services are performed following or exceeding all current rules and regulations for the protection of health, safety and environment. We perform work to the highest quality standards and comply with EU and FDA regulatory requirements, company operating procedures and testing methods. We also commit to continuous improvement and implementation of better processes and organizational efficiencies.
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 Q7.
Every employee receives training in cGMP and standard operating procedures. R&D and production staff is trained in laboratory techniques and methods as well. Our independent quality assurance department reviews all data and procedures. ChemCon´s APIs are subject to full qualified persons release. Our quality review process provides assurance of the quality system and the effectiveness of corrective and preventative actions (CAPA). Routine internal and external quality audits for cGMP compliance assure that our quality systems are consistent with current industry standards.
For details about our Quality Assurance Management, please refer to the article Drug Quality Assurance: Systems at ChemCon.