Company strategy: Quality policy
At Celonic Group our Quality Assurance and Quality Management departments are dedicated to assuring exceptional product quality, and meticulously follow industry standards for patient safety. Our core values of empathy, efficiency and excellence in everything we do, enable us to deliver high customer satisfaction.
We listen attentively to our clients and leverage our extensive experience and deep industry knowledge to deliver innovative solutions that perfectly respond to their requirements and exceed their expectations.
Another secret to our success is our strong focus on employee satisfaction. Mutual respect and appreciation are central to our working culture, as also is our commitment to cross-functional continuous improvement. Indeed, it is this dedication to quality in our every thought and deed that enables us to attain such high stakeholder satisfaction.
Certified manufacturing excellence
Celonic Group lives by the principles of Quality by Design and we apply Total Quality Management (TQM) methodologies throughout our organization. This extends across our manufacturing sites, where we strive to deliver the highest quality solutions for biologic production. Our risk management policy based on ICH Q9 (Quality Risk Management) makes optimal use of the available resources to ensure reliable and safe processes, with a focus on product quality for GMP relevant activities.
Both our German and Swiss facilities have EU commercial good manufacturing practices (cGMP) certification for active biopharmaceutical ingredients (bio APIs) from cell of human or animal origin as well as for aseptic clinical samples (for analytical tests). They are also both subject to periodic independent inspection, in Germany by the Regierungspraesidium Tuebigen, and in Switzerland by Swissmedic. Furthermore, we receive numerous yearly visits and audits from our clients, and from local and international regulatory authorities.
Proven and established Quality Management Platform
From an internal perspective, we ensure exceptional customer service, regulatory compliance and product quality through our new in-house quality management platform: TrackWise Digital QMS from Sparta Systems, Inc. Offering combined documentation and quality management functionalities, this solution allows us to more effectively target and reliably meet our customers’ needs concerning their biopharmaceutical drug substances and drug products. Of course, the system is only as strong as its users, so we also ensure full training for every employee in its optimal implementation according to the latest Standard Operating Procedures (SOPs), supported by cross-functional continuous improvement initiatives.
Behind this commitment to excellence and quality is a highly experienced and motivated quality control team, driven by Celonic Group’s strong core values and culture. Our work focuses continuously on the improvement of our development and process environment to become a premium Contact Development and Manufacturing Organization (CDMO), offering the best tailored biopharmaceutical solutions to our valued clients.
Celonic is your partner over the whole life cycle of your lead protein candidate from discovery to market supply.