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Quality is the life and reputation of a company. Good quality assurance system, scientific quality assurance methods, high precision analytical instruments and accurate procedures and performances provide a good assurance for quality. The quality assurance department was formed in 2002 for the control of the all processes of drug production in compliance with GMP. The in-house standards are established in accordance with the Chinese Pharmacopoeia, but exceed the specifications of the pharmacopoeia as the standards in major foreign pharmacopoeias are also carefully studies and referenced. The QualityControlCenter checks quality at all key processes from raw material receiving to finish product shipment.
The company adopts the approach of “best quality and superior reputation” and the management philosophy of “superior quality and service”. The company continuously improves the quality in accordance GMP requirement and created many name brands and received many awards. Since 1995, the company received many awards such as “National Class Two Enterprise”, “Good Quality and Efficiency”, “Excellence in Quality Management” from State Food and Drug Administration, Ministry of Health, Heilongjiang Provincial Quality Management Association. The company received product award on the stabilized improvement in quality of Yisalin, Cafotaxime sodium for injection in 2000. The company received the awards of “most satisfactory by customers”, “most satisfactory services” “most satisfactory products for penicillin sodium, cefazolin sodium, cefotaxime sodium, cefradine, Yisalin” in 2002. The company’s penicillin and cephalosporin were evaluated as HeilongjiangProvince’s name brand products in 2000-2004. The company received national award for excellence in quality management in 2004.
The company’s penicillin and cephalosporin injection powder and APIs received GMP certificates in 2000, which made the company within the first GMP compliant companies in China. The company received GMP certificates for tablets (cephalosporins included) capsules, granules (penicillins and cephalosporins included), powder for injection (Bolier) in 2001. In 2002, the company’s tablets (penicillins), APIs (leucomycintartrate, azithromycin Lactobionate), powder for injection (non-β-lactam) received GMP certificates, which made all of the company’s products are GMP compliant. In 2003, all new dosages, products, and production lines or change in processes and equipments are certified in accordance with government regulations and were GMP certified. The company received new GMP certificates for powder for injection (cephalosporins) sterile APIs (penicillin sodium), powder for injection (cephalosporins and penicillins) in 2003. In the same year, workshop 118 and 213 are GMP certified. In 2004, sterile APIs (ceftriaxone sodium, ceftezole sodium, amoxicillin sodium, sulbactam sodium, cefradine), APIs (cephalexin, cefradine, Cefetamet Pivoxil Hydrochloride, amoxicillin, quinapril hydrochloride, calcium gluconate, zinc gluconate, sultamicillin tosilate, itopride hydrochloride), sterile APIs (penicillin sodium), powder for injection (cephalosporins), soft capsules, suspensions, suppositories, soft gels, sterile APIs (ceftizoxime sodium, cefoperazone sodium), sterile API (ampicillin sodium) received GMP certificates. Now all the company’s products are GMP compliant. The company was certified by ISO9001 quality system and ISO14001 environment control and employee safety and health control system. Now Harbin Pharma’s products are gaining worldwide reputations. Harbin Pharma will have an even more brilliant future.
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