Quality Systems

St. Francis, Wisconsin USA

Kingchem’s St. Francis, Wisconsin (USA) facility conforms with current Good Manufacturing Practices. The manufacturing and quality systems strictly adhere to ICH Q7 standards for Active Pharmaceutical Ingredients. ICH quality guidelines are incorporated into all aspects of our business. An effective Quality Management System led by our Quality Assurance group helps to achieve products that are consistently manufactured and controlled. Our St. Francis plant is also registered under the U.S. FDA’s Drug Establishment Registration and is subject to routine inspections by the FDA.

Fuxin, Liaoning, China

Our Fuxin, Liaoning (China) facility has long had in place Quality Management systems conforming with GB/T19001 for all operations, including R&D and production. In order to conform to the requirements from our pharmaceutical customers, elements of ICH-Q7 are integrated into our quality management system with full QA oversight. As well, the Fuxin plant has also successfully passed numerous quality audits from top multi-national pharmaceutical companies over the years.

By incorporating elements of ICH-Q7 standards, such as material management, cross contamination control, equipment cleaning, qualification and maintenance, batch record, QC management, deviation management and change control management, we ensure that your starting material or key intermediate conforms to the standards you need. The plant also routinely operates under strict quality agreements in place with our customers.

Contact us and let us show you how we can successfully run a campaign on your behalf to deliver starting materials governed by your quality agreement.