Strategy Stuty For Sterile Medicines Manufacturers Implementing GMP(2010 Version)

Good Manufacturing Practice (GMP) is an effective way for medicines production and quality management, which has been widely used in the world for many years. GMP provides special requirements for all aspects related to the medicines production, including raw materials, facilities, equipments, hygiene, personnel training and quality management etc.,. GMP can decrease the risk of contamination and error during the whole production process, and provide assurance for the safety and good quality of medicines.GMP is dynamic system, which should be updated at the proper time to keep its rationality and feasibility with the development of pharmaceutical industry and the change of domestic and overseas medicines supervising environments. The previous GMP in China was revised in 1998, and put into effective on August 1, 1999. The State Food and Drug Administration (SFDA) carried out staging mandatory certification to make the GMP management are normalized step by step during more than ten years. But with the rapid development of Chinese pharmaceutical industry, the current GMP can not meet improve the safety and quality of medicine produces, and even become a barrier for China pharmaceutical enterprises deeply participating international marketing competition. In order to comply with the new conditions, SFDA have been revising the GMP since September 2006.Now the new revised GMP has been put into effective on March 1, 2011.The annex for sterile medicines is one of the updating focuses. In order to help the sterile medicines manufacturers understand and implement the requirement of new GMP properly, the articles analyze the changes of requirements for sterile medicines of new GMP compared with the GMP (1998 Version) and the potential effects of new GMP, and then puts forward some strategies which should be considered by sterile medicines manufacturers in prior to renew certification. Finally,by the successful EU GMP certification of NCPC Huari, give the further explanation for these strategies.The articles adopt comparative analysis, experience summary, case study and analogy method, etc. Researches results show that, if the sterile medicines manufacturers be influenced by new GMP mostly, can have a rational view on the GMP updating, understood its essence requirements, and know every special change, they could take proper and effective measures to face the challenge brought by the new GMP and achieve the long-term good development.