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Website: www.nkf-pharma.com
Email: nkf-pharma@nkf-pharma.com.cn
quality
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"The quality of product relates to the life of enterprise, while the quality of drug product relates to the life of people." Quality is the basis on which an enterprise exists and develops. NKF has established a standardized quality management system up to the international standards to implement the strict and overall quality control over all aspects throughout the whole manufacturing process; the dedicated equipment and precision testing instruments equipped by NKF exceed the compendial requirements of China,Europe,U.S. and other countries, and provide a reliable technical guarantee for the product quality of NKF. Because of the standardized and mature operation of quality management system, the heparin API and finished dosage products of NKF have passed the official certification of CFDA, U.S.FDA, etc. and also recoganized by customers of Fortune Global 500 pharmaceutical companies.

NKF has established a series of quality management system documents including quality standards, manufacturing process procedures, standard operating procedures (SOP), etc. in accordance wtih the requirements of China GMP, U.S. FDA cGMP, EU GMP, ICH Q7A, etc. NKF has a high-quality team with advanced Eurpoean and American GMP management experience. Besides, regular, continuous and intensive personnel trainings are perfored to enhance all employees' awareness of quality, awareness of implementation strictly according to procedures,as well as the skills of standard operation and high-quality work.NKF supervises and controls the critical process parameters and quality control points throughout the whole manufacturing process through scientific planning and ordered organizaton,so as to control quality risks and effectively guarantee the product quality,and to provide customers with safe, effetive and higher quality drug products.

  • Liquid distribution test
    Impurity treatment
    Experimental equipment
  • Determination of molar ratio
    liquid dissolution
    UV control
  • Map analysis
    Liquid distribution test
    Impurity treatment