Quality Management

Cellex is offering various services related to cellular therapies, e.g. cell collection, production of ATMPs under GMP, research and development, clinical trials, transports and logistics. All these services have to apply to various laws and guidelines (Good Manufacturing / Distribution / Clinical / Laboratory Practice) or summarized as GxP. 

The common basis of all regulations is the requirement of a functioning quality management or quality assurance system as a prerequisite for all activities. Every pharmaceutical company is obliged to introduce, maintain and document a functioning quality management system including its control, in accordance with the type and scope of its activities. 
Despite all the specifics of the different regulations, many requirements are similar or the same for the different areas. Therefore all companies of the Cellex Group work under the umbrella of a common quality management system.

Quality means safe products in compliance with the relevant regulatory framework conditions, pioneering innovations and comprehensive service for donors and patients. Systematic control of processes within the group ensures efficiency and cost-effectiveness. Identifying opportunities and risks and looking for improvements are integral parts of the work of the management and all employees.

Quality management takes on the responsibility to create optimal conditions for the fulfillment of the stated goals.