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                Stock Code:002675
                Quality assurance

                        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.

                CONTACT US
                Address:No.7 ChangBaiShan Road, Yantai Development Zone, ShanDong, China