 Cambrex Pharma is committed to the manufacture of premium quality products in compliance with regulatory requirements and customer expectations. Patient safety and environmental concern is the foundation of our operations and the basis for all our work.
We work in accordance with cGMP requirements and operate according to the US Food and Drug Administration (FDA), European (EMEA, MRHA, MPA) and International Conference on Harmonisation (ICH) guidelines and regulations. Our sites are successfully inspected by the FDA on a regular basis.
We have many years of experience preparing and maintaining Drug Master Files (DMFs), and today, we hold more than 100 DMF:s. With our experience in developing many drug substances from early trials through to launch and commercial supply, we have gained valuable experience in determining what will be the important quality factors for customer's success in all phases from discovery to market.
We are also proud to maintain reliable cGMP operations, while offering flexible solutions to changing customer needs. Our employees are our most valuable resource. Cambrex continuously offers its employees quality and safety training, to ensure commitment to our regulatory requirements and to meet the increasing demands from customers and regulatory authorities.
Responsible Care
Cambrex Pharma is also committed to the Responsible Care program and it is included in our day-to-day operations. We place a strong emphasis on the safety of our processes and minimization of their effects on the surrounding environment. At several sites, we conduct environmental analyses internally to ensure minimum impact. Our objective is not only to comply with the environmental regulations, but to surpass it whenever possible. Regular audits by customers and regulatory authorities are the basis for continuous improvements in our facilities and processes. We also perform regular internal quality audits as a powerful tool to keep focus on the importance of work in accordance with cGMP and Responsible Care. Cambrex Charles City was the 2004 recipient of the SOCMA Responsible Care Excellence award for medium sized companies.
Wastewater treatment plant at Cambrex Karlskoga.
cGMP and ISO 14001
To further support our operations we have process oriented quality management systems that give us a structured approach to maintaining quality assurance, cGMP compliance and Responsible Care practices. Our European sites operate the ISO quality management system. In 2002 Cambrex was proud to receive ISO 14001 certification for the environmental programs at it's main site in Karlskoga, Sweden
Regulatory
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