Challenges And Actions For Injections Production Triggered By GMP2010

New GMP international, domestic better reflect the overall pooled and absorbed the views of national and even international counterparts, reflecting the concept of scientific development concept, to enhance the international competitiveness of the pharmaceutical manufacturing enterprises in China will have a profound impact.The most prominent new GMP Amendment change China’s new GMP in sterile drug injections part with international standards, and significantly improve the quality monitoring requirements of sterile Pharmaceuticals (injections) production, the core of the highlights. The difference is that of sterile products and other products can not contain any living micro-organisms, and intravenous use must conform to the limits of bacterial endotoxin requirements. Injection production from the new GMP requires the presence of a large gap, such as the current one hundred B level amounted to less than a new GMP requirements, moist heat sterilization method of terminal sterilization FO value of less than8minutes of training based validation does not meet the new GMP requirements, and so on.This project based on domestic injections production enterprises smoothly through the new version of GMP certification of purposes, the use of risk management, data chart analysis, key points of control (HACCP) and other tools of the new GMP sterile pharmaceuticals (Injection) is now the production challenges of the conditions for analysis, combined with the actual situation of the enterprise, from the sterile definition, environmental control, isolation operation, sterile production process validation, sterilization problems, the new requirements of the new GMP risk analysis study, combined with injections of the enterprise production workshop actual proposed response measures and rehabilitation programs, from plant layout transformation, the transformation of a sterile environment, air-conditioning system transformation, blowing potting the linkage line of a laminar flow hood transformation, online detection system transformation of all aspects of the response measures, as the basis for the transformation of the enterprise workshops GMP of2013passed a new version of GMP certification, and provide reference to similar injections enterprise views.