Quality assurance

Quality By Design,Control,Innovation

Quality by design is an approach that aims to ensure the quality of medicines by employing statistical, analytical and risk-management methodology in the design, development and manufacturing of medicines.

International Manufacture Facility

Beijing Kanghong Biomedical Co.,Ltd.

Beijing Kanghong Biomedical Co.,Ltd. includes a biopharmaceutical commercial manufacturing plant and supporting facilities designed and constructed according to NMPA GMP and EMA&FDA cGMP regulations,and the total area is 140,000m².

This manufature site shall facilitate the technological advances and new product production.

Pharmaceutical Supply System

In order to improve the level of software and hardware within the manufacturing system, and to ensure stability in the quality of essential pharmaceuticals, Kanghong has established a number of GAP cultivation bases, hence creating a supply system for medicinal materials that integrates coordination, cooperation, and internal bases.

By establishing standards and sources, the company has formalized cooperative relations with farmers and original suppliers. This allows the company to enhance quality supervision of the sourcing process and collect traceable digital information right from the start, so as to achieve the safe manufacture of pharmaceuticals right from the "source".

Quality System
  • Quality management system

    Based on the ISO9001 quality management system, FDA's six-system inspection model, EU quality system, and ICH Q10 model, Kanghong conducts the whole process quality control of product development, production and circulation.

  • Continuous optimization and improvement

    During the process of establishing a quality management system,Kanghong Pharmaceutical is committed to the improvement and optimization of standards. The company has refined specific technical guidelines in accordance with the GMP, ICH, PDA, and ISPE of the United States, Europe, and Japan. Furthermore, former inspectors from the United States or Europe have been employed in conducting audits or mock inspections, to help the company in improving and optimizing standards.

  • Quality Control Throughout the Product Life Cycle

    By adhering strictly to the requirements of "data integrity" at all stages of the product life cycle, Kanghong Pharmaceutical guarantees consistent and reliable quality throughout the entire process of manufacture and operation.