Cambrex’s custom manufacturing services are fully integrated, from analytical and process validation to finished dosage formulation for both non-cGMP and cGMP products.
For cGMP manufacturing, Cambrex has an uncompromising commitment to cGMP standards, a proven track record of compliance with EH&S regulations and facilities that are approved to manufacture commercial APIs under cGMP.
- cGMP compliance consistent with stage of development
- Strong regulatory track record in supporting regulatory submissions
- Qualified instrumentation and facilities
Continuous Process Improvement through Six Sigma
Six Sigma is an improvement tool designed to measure and to systematically eliminate defects and variability in a process. Cambrex actively incorporates Six Sigma into manufacturing and business processes to consistently deliver efficient, high quality and cost competitive products with less time to market for our clients. The formal program was initiated globally in 2004.
Cambrex employs several full-time Six Sigma Coordinators, also known as Black Belts, who work to implement improvements prior to initiating manufacturing campaigns using Design for Six Sigma (DFSS). As a result, we create a team approach to improvements with real time analysis trending. Our Six Sigma road map is well defined for effective work and project success.
Our strong focus in continuous process improvement through Six Sigma allows us to:
- Decrease variability to consistently produce quality products
- Reduce costs from defects, cycle time and raw materials to meet customer supply needs
- Improve the design of new manufacturing processes
- Identify and eliminate activities that do not add value
- Promote greater flow with maximum productivity, capacity and throughput
- Increase robustness and process capabilities