Manufacturing & Quality Platform
In accordance with the regulatory requirements and standards in China, the United States and Europe, Kelun-Biotech has established a robust quality management system applicable to biological products and chemical drugs. The quality management system covers the entire innovative drug life cycle from drug design and development, clinical trial sample production, technology transfer, commercial production, to withdrawal from the market. Throughout the drug lifecycle there are carefully organized and planned activities to ensure that the quality of the drug products are in line with the intended use. The ultimate goal is to eliminate contamination, cross-contamination, confusion and errors during the production of pharmaceutical products. Kelun-Biotech systematically implements all the safety, efficacy and quality control requirements of drug registrations during the entire process of drug production, process control, product release, storage and delivery to ensure the continuous and reliable production of drugs in compliance with the intended use and registration requirements and ensure drug safety for patients. Kelun-Biotech stringently advocates a sustainable quality-oriented culture focused on quality and integrity to ensure that the safety and effectiveness of products. Patient safety, data integrity and stakeholder trust are Kelun-Biotechs top priority.
