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    发布日期:2020-05-24浏览次数:字号:[ ]

    API工厂目前包括6大系列产品:肝素系列,硫酸软骨素系列,氨糖系列,细胞色素C系列,胶原蛋白系列以及透明质酸系列,拥有6个生产车间。作为国内生化原料药生产基地之一,原料药产品肝素钠及硫酸软骨素凭借工艺、可靠质量,赢得了卓越的国际权威机构认证,产品90%以上销往欧盟、美洲、亚太等30多个国家和地区,与众多全球知名药企建立了长期稳定的合作关系。
    公司依据cGMP、ICH Q7、ISO9001:2008要求建立了完善的质量管理体系,QA职能渗透到所有GMP相关部门,为公司产品质量和新产品开发奠定了夯实的基础。东诚药业自2000年ICH Q7颁布并逐渐成为全球原料药良好生产规范以来,就逐步按照GMP(ICH Q7)的规范要求,①整合质量管理系统;②更新升级GMP软硬件;③加强开展全员GMP培训,东诚药业由此不断提高原料药生产的GMP(ICH Q7)符合性,为原料药质量的恒稳性提供高度保障。通过学习现代GMP(ICH Q7)概念与规范,理解“质量来源于设计”、“质量来源于工艺控制”的现代质量观念,通过对研发、注册、采购、仓储、生产、工程、设备、质控、文件等方面的功能部门与资源的整合,建立了一个包括设施设备系统、物料系统、生产系统、质控系统、质保系统在内的符合现代GMP(ICH Q7)要求的高效率质量管理系统,为原料药生产的质量管理提供了一个符合美欧GMP要求的现代化平台。

    公司拥有一批高责任心且富有专业经验的药物分析人员,参与EP、USP和 Ch.P.药典修订工作,化验室还引进相当数量硕士学历的分析人才承担新方法开发和验证工作,开展日常分析检测工作,能满足各国药典以及客户不同的规格标准要求。化验室拥有一系列国际领先的分析仪器,包括核磁共振仪、高效液相色谱仪、顶空气相色谱仪、离子色谱仪、红外分光光度计、原子吸收分光光度计,紫外-可见分光光度计及自动定位滴定仪等,化验室建立了专门的PCR和微生物室,完全能满足生产所需的不同原料及产成品的检测需求。
    公司自成立以来,一直严格遵守ISO9001和GMP的要求,秉承着“把质量、顾客、承诺视为企业的生命”的质量方针。公司于2000年首次通过国家药监部门的GMP认证,2001年5月首次通过挪威船级社DNV的ISO9001质量体系认证, 2004年4月公司肝素钠产品首次通过了德国汉堡卫生当局的GMP认证,2005年首次取得了肝素钠CEP证书,2006年公司硫酸软骨素钠产品首次通过美国USP的认证,2009年2月公司肝素钠产品首次以零483通过了美国FDA认证,2009年12月公司肝素钠产品首次通过了韩国MFDS的GMP认证,2009年9月公司硫酸软骨素钠产品首次通过巴西ANVISA的GMP认证,2010年首次取得了硫酸软骨素钠CEP证书, 2011年07月公司肝素钠产品首次通过了日本PMDA的GMP认证,2011年8月公司硫酸软骨素钠产品首次通过了德国汉堡卫生当局的GMP检查。公司在与官方和客户不断沟通中,我们的质量管理水平持续改进着。
     
    DCB now is one of the biggest biochemical API manufacturers in China, With leading production technology, reliable product quality and excellent international qualification background, the company’s Heparin sodium and Chondroitin Sulfate products have hold important place in global market . Currently 90% of DCB API products are for export, thanks to company’s well-established global sales network, our API products have been exported to more than fifty countries and regions, including USA,Germany,Austria, Japan etc. Currently, there are 6 series of products: heparin series, chondroitin sulfate series, glucosamin series, cytochrome C series, collagen series and hyaluronic acid series, with 6 production workshops.
    Based on requirements of cGMP、ICH Q7 and ISO09001:2008, perfect Quality Assurance System is established in Yantai Dongcheng Biochemicals Co., Ltd, which provides strong support to our high quality products and new products development. 
    Since we achieved State Food and Drug Administration’s GMP certification in 2000, Yantai Dongcheng has always strictly followed requirements of ISO and GMP, and considers our Quality Policy-“Quality, Customers and Commitment” as our company’s philosophy of operation. In May 2001, Dongcheng achieved DNV ISO9001 International Quality System certification. In April 2004 and May 2007, Dongcheng passed the GMP inspection from Germany Hamburg BSG. In January 2005, Dongcheng achieved Heparin Sodium CEP certificate from EU EDQM. After “Baxter incident” in March 2008, Dongcheng passed the GMP inspection from Germany Hamburg BSG for the 3rd time and achieved GMP certificate. Furthermore, for Heparin Sodium, Dongcheng passed the 4-day GMP inspection from FDA without any 483 deficiency. In October 2010, Dongcheng achieved he latest revised Heparin Sodium CEP certificate from EDQM. In 2006, Dongcheng’s Chondroitin Sulfate Sodium was certified as dietary supplement by USP, and in May 2010, Dongcheng achieved Chondroitin Sulfate Sodium CEP certificate from EU EDQM. With the frequent quality inspection and regular customers’ audit, our management system and the capability of quality management improvement have given our customers favorable impression.
    Our pharmaceutical analysis personnel have strong sense of responsibility and extensive professional experience. They carry out routinely pharmaceutical analysis and quality examination. Dongcheng’s products can meet each country’s pharmacopoeia and various specifications of different clients. Our lab is equipped with advanced test instruments such as High Performance Liquid Chromatograph, Gas Chromatography, Ion Chromatograph, Infrared Spectrophotometer, Atomic Adsorption Spectrophotometer, Ultraviolet-visible Light Detector, Automatic Potentiometeric Titration Meter etc. our lab established special PCR and Microbial room, which is capable of undertaking various raw materials and finished products tests. Our lab has also brought in analysis talents with Master degree to take on new methods’ development and validation. All relevant documents and records are strictly managed and under orderly control.
     Since ICH Q7 promulgated in 2000 and gradually became the GMP of the world API, Dongcheng Biochemicals gradually integrates quality system, updates GMP software and hardware and strengthens the GMP training for the staff as the requirements of GMP(ICH Q7). DCB continuously improves the GMP(ICH Q7)compliance of Heparin Sodium API to provide assurance to quality stability of API. According to the requirements of GMP、ICH Q7、ISO9001:2008, the company establishes perfect quality assurance system, which has abundant quality management experience and high quality management level in order to provide powerful support to the high quality products. By learning modern GMP(ICH Q7)concept and standard, we understand the modern quality concept that “quality comes from design” and “quality comes from technical control”. Through the integration of function department and resources in R & D, registration, purchasing, storage, production, engineering, facilities, quality control and files etc., the company establishes an efficient quality management system. This system includes facility system, material system, production system, quality control system and quality assurance system that satisfy the requirements of modern GMP(ICH Q7). The establishment of the quality management system according to the requirements of American and European GMP provides a modern platform for the quality management of API production.
    The perfect quality assurance system gets approval from many countries and districts. At present, our company has achieved FDA, Germany Hamburg, PMDA and MFDS registration. All these certificates have proved the quality assurance system of our company is in a high level.
     
    2 公司网址:www.dcb-group.com

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