Quality Control_Innovation_China National Biotec Group Company Limited

Quality Management Policy

  • supreme qualit
  • customer satisfaction
  • risk control
  • continuous improvement

Quality Management System

质量管理体系

In keeping with the GMP, EU GMP and ISO9001 standards and ICH Q10 guideline, CNBG has established a quality control system that covers the whole product life cycle, from R&D, technology transfer, production and marketing to expiration. The approach based on science and risk control has ensured continuous improvement in every step of the whole product life cycle.

Domestic and international certification

  • GMP authentication

    Seven human vaccine producers, five blood product producers,
    and one medical aesthetics company have the 2010 GMP authentication
    Two animal vaccine producers have the GMP authentication
    By 2018 CNBG had obtained 40-plus GMP certificates

  • WHO prequalification

    2013: Encephalitis B attenuated live vaccine developed by Chengdu Institute of Biological Products Co., Ltd. became the first of its kind in China that won the WHO prequalification
    2017: The inactivated bivalent poliovirus vaccine bOPV developed by Beijing Institute of Biological Products received the WHO prequalification

  • Triple certifications

    Changchun Keygen Biological Products Co., Ltd. and Chengdu Rongsheng Pharmaceuticals Co., Ltd. have obtained ISO9000 quality management, ISO14000 environmental management, and OHSAS18000 health & safety management certifications.

  • Overseas registration and certification

    Several products have passed certifications of drug administrations of other countries
    Chickenpox vaccine developed by Changchun Keygen Biological Products Co., Ltd., which is owned by Changchun Institute of Biological Products Co., Ltd., passed certifications from the Republic of Korea, India and Cote d'Ivoire
    Encephalitis B attenuated live vaccine developed by Chengdu Institute of Biological Products Co., Ltd. passed certifications from the Republic of Korea, Nepal and the Philippines
    Pneumococcal polysaccharide vaccine (23-valent) developed by Chengdu Institute of Biological Products Co., Ltd. passed the certification from Cote d'Ivoire
    Botulinum Toxin A developed by Lankai Company under Lanzhou Institute of Biological Products Co., Ltd. passed certifications from Peru and Turkey
    Gamma globulin (intravenous) of Chengdu Rongsheng Pharmaceuticals Co., Ltd. under Beijing Tiantan Biological Products Co., Ltd. passed certification from Turkey

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