In accordance with the requirements of regulations and standards in China, the United States and Europe, Kelun-Biotech has established a robust quality management system (QMS) applicable to biological products and chemical drugs. The QMS covers the entire life cycle of innovative drugs from drug design and development, sample production for clinical trials, technology transfer, commercial production and withdrawal from the market. The QMS at its core includes organized and planned activities to ensure that the quality of the drug product is in line with the intended use. The goal of the QMS is to minimize contamination, cross-contamination, confusion and errors in the production of pharmaceutical products. Kelun-Biotech systematically implements all the safety, effectiveness and quality control requirements of drug registration into the whole process of drug production, control, product release, storage and delivery. The primary goal of the QMS is to ensure the continuous and stable production of drugs in compliance with the intended use and registration requirements and the drug safety for patients.
Kelun-Biotech advocates a continuous improvement, quality-oriented culture centered on quality and integrity. Kelun-Biotech’s top priority is the assurance of the safety and efficacy of its products, patient safety, data integrity and stakeholder trust.
