Following Yangtze River Pharmaceutical Group Co., Ltd. and Guangzhou Hairui Pharmaceutical Co., Ltd., Yangtze River Pharmaceutical Group's Nanjing Hailing Pharmaceutical Co., Ltd. passed the EU GMP on-site test in April, opening the door to European Union market for its solid preparation.
From April 8 to 11, Hailing allowed two experts arranged by German State of Baden-Wuerttemberg conduct GMP on-site check for its sotalol hydrochloride tablets in accordance with EU GMP requirements. The team of experts learnt about the basic conditions of Yangtze River Pharmaceutical Group and Hailing Pharmaceutical Co., Ltd., and then conducted a full check on the quality management, institutions and personnel, factories and equipment, facilities, raw materials and products, confirmation and tests, document management, production management, quality control and quality guarantee, entrusted production and entrusted tests, shipment and recalling of products, self-check, etc.
During the check, Hailing responded to the test with its professional knowledge, proficient skills and repose. The team of experts confirmed the operation of EU GMP, and explained and gave valuable suggestions and opinions on the specific issues. During the check of the final conference, the inspectors and experts declared the Hailing Pharmaceutical Co., Ltd. pass the test.
Li Fang, Hailing's vice general manager, said that Hailing would continue to see requirements by EU inspectors and experts as the standards, reform, adjust and take this opportunity to bring up the quality management. This EU GMP test was an inspection to the production and quality of Hailing and would boost the further development of Hailing in the future.
Hailing passed the GMP certification on its tablets, capsules, granules in August 2012. It also passed GMP certification on new large-volume injection and small-volume injection in September 2012.