生产质量管理体系

华北制药华坤河北生物技术有限公司利用合资方优势资源，系统搭建了肝素系列产品、蜂毒产品的生产平台，产品产业链完整，统一经营。

Utilizing resources advantages of shareholders, Huakun Biotech established Heparin System products and Bee Venom manufacturing platforms, the product chain is complete and unified.

肝素钠粗品生产基地，设计年产能3600亿单位。来源于国内规模生猪屠宰集团或企业的高品质生猪及时新鲜的猪小肠黏膜采集。稳定持续的黏膜供应，确保肝素产业链系列产品能够做到真正意义上的可追溯及全程可控。

The designed annual capability of Heparin Sodium Crude production base is 360billion units. All the porcine intestinal mucosa used to produce the heparin series products in Huakun Biotech are freshly collected from scale pig slaughtering group of China. The whole process traceability and controllability can be ensured authentically by stable and continuous mucosal supply.

肝素系列原料药生产基地，肝素钠设计年产能8000亿单位，依诺肝素钠和那屈肝素钙设计年产能400kg。先进的设计理念、高标准的技术装备、专业严格的质量管理体系、整洁的环境有效保证了产品质量。

In the heparin series APIs production base, the designed annual capability of Heparin Sodium is 800 billion units, Enoxaparin Sodium and Nadroparin Sodium is 400kg. Advanced and professional design concept, high level equipment, strict quality management system effectively ensures product quality.

注射用蜂毒的生产基地，由华北制药于2011年斥资20亿元人民币建成。该基地采用国内先进的设计理念，装备了世界先进的生产设备，高素质的专业团队和完备的质量管理体系全面保障生产供应。目前各条生产线均已通过中国GMP认证，且注射剂生产线通过了WHO GMP现场检查。

Toxic Apis for Injection is manufactured in North China Pharmaceutical Co., Ltd. It was established in 2011 with a cost of 2 billion RMB. The base adopts domestic advanced design concept and is equipped with the world's advanced production equipment，has a professional team and established perfect quality management system to ensure high quality product supply. By now, all the production lines were got the Chinese GMP certificates and the injection production line was passed the WHO GMP inspection.

华北制药华坤河北生物技术有限公司按国家新《药品管理法》规定，建立了与药品上市许可持有人制度相匹配的公司质量管理体系，对药品全生命周期进行管控，确保药品研制、生产、经营、使用全过程中的安全性、有效性和质量可控性。

According to the new Drug Administration Law of the State, Huakun has established the quality management system that matching the MAH regulation, to control all the activities throughout the life cycle of the products, from R&D, production, distribution to utilization, to ensure the product’s safety, effectiveness and quality in control.

未来“华药华坤”将持续坚持生产技术及质量管理高投入，不断提升公司生产及质量管理能力，全力助推公司各阶段战略发展目标的完成。

In the future, Huakun will continue the high investment in technology improvement and quality management, constantly improve the production and quality management, make every effort to ensure the achievement of the company’s strategic goals at all stages.

中国书法家协会会员刘熙墨手书

中国书画家协会理事赵文岱作品