CMC Biologics Quality Unit
The CMC Biologics Quality Unit consists of the Quality Control Department (QC) and the Quality Assurance Department (QA).The Quality Unit provides and maintains the cGMP quality system to support all aspects of biopharmaceutical product manufacturing and to fulfill all present regulatory requirements.

Operating as a CMO demands constant evaluation of our quality systems by our customers. Therefore the Quality Unit works closely with internal and customer project teams to meet project requirements and ensure full regulatory compliance.  We are committed to continuous quality improvement and our goal is to provide the biopharmaceutical products to our customers that meet highest safety and quality standards.  

Quality Control Department
The main objectives of the QC Department are control of raw materials, in-process, stability and release testing analyses for CMC’s customers. In addition, QC is responsible for the microbiological control of products and the production facilities.

• Testing of cell banks, raw materials, and other materials for cGMP production
• Monitoring of critical product contact utilities (WFI, HPW, clean steam and compressed air) for cGMP production
• Handling of raw material and product reference samples
• Analytical method development and validation
• In-process, intermediate and final product release testing (bulk drug substance, drug product)  
• Analyses of samples from process and cleaning validation studies
• Process characterization studies
• Environmental monitoring of classified cGMP production areas
• ICH compliant cGMP stability program (intermediates, bulk drug substance, drug product and placebo)
• Cell based bioassays

Quality Assurance Department
The main objectives of our Quality Assurance Department are enhancement of product and service quality, continuous quality improvement, QP release of batches, and to secure high customer satisfaction.

• Disposition of bulk drug substance 
• Cell bank and raw material release
• Qualified Person release of IMP & DP
• cGMP and regulatory support (e.g. IND, IMPD)
• Quality Agreements with customers and suppliers
• Audit of external suppliers and contract laboratories
• Deviation and CAPA systems
• Change Management system
• Continuous improvement of our Quality System effectiveness.
• Staff training and compliance with the requirements of the quality system
• Qualification and validation of equipment, process, products & cleaning
• Regulatory Support