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Quality Assurance and Regulatory Support

As a partner to pharmaceutical, biotechnology, and chemical companies, quality is the center of ChemCon’s activities. 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 batches with a Certificate of Compliance issued and produced at its 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 current Good Manufacturing Practice (cGMP) and standard operating procedures (SOPs). Internal routine audits and external inspections assure that our quality systems are consistent with current GMP industry standards at all times. Our independent quality assurance department reviews all data and procedures. The review process also includes effectiveness of corrective and preventative actions (CAPA).

For more details regarding customers audits and inspections, please refer to the sections on the left.

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