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Testing
Celonic launches stand-alone GMP analytics portfolio
Challenging positions in upstream processing
Corporate Quality Policy
Quality Means Safety
We ensure that our products and services meet official requirements. Our goal is to ensure the maximum benefit at minimum risks.
Quality Demands Responsibility
The Quality Management System is regularly monitored for compliance and effectiveness internally and by European authorities. Our Quality Assurance Officers are responsible for the planning, monitoring, up-dating and further development of the Quality Assurance System.
What does this mean?
The Quality Management System is complying with three different regulatory areas.
The Basel facility is certified by SwissMedic according to GMP since 2006. The last inspection to place in 2009. The next inspection is expected in 2011.
Our Jülich laboratories were first time certified according to DIN ISO 9001 in 1999. The most recent recertification by the German Society for Certification of Management Systems (DQS) took place in February 2010. We are GLP certified since 3 years in addition to that.
Download “GLP-Certificate,pdf”
Download “GMP-Certificate.pdf”
Key words: Cellonic, Contract Manufacturing Organization, Contract Analytic, Contract Research, Cell line development, regulatory conform, GMP, cGMP, non-GMP, GMP-like, GLP, GCP, manufacturing, GMP manufacturing license, biologic material, recombinant monoclonal antibody, recombinant protein, pre-clinical, clinical study material, market supply manufacturing, stability testing, Quality Control, validation batches, lots, downscale model, virus validation study, reference standard, Drug Substance, Drug Product, quality strategy, GLP-analytics, biopharmaceuticals, biosimilar, biotechnology, EMA, EMEA, FDA, proof of concept, regulatory affairs, quality management, quality assurance, immune therapeutics, cancer therapeutics, large scale manufacturing, human like glycosylation structure, virus-filtration, sterile filtration, Bioburden reduction, cleaning validation, WFI, documentation, SOP, instruction, Master Batch Record, quality management handbook, clean rooms, class C
