New 高标准 and regulatory approval, drug recalls, adverse reaction monitoring and other aspects of regulatory requirements is how effective convergence? New 高标准 stressed and drug registration, drug recalls, adverse drug reaction monitoring other regulatory aspects of effective convergence. Production quality management process for regulatory approval of drugs is required to implement and reflect. In several chapters of the new 高标准 "production management", "quality management", "commissioned the production and inspection commission" and has emphasized the conformity of production requirements and regulatory approval requirements. New 高标准 also note with "drug recall management approach" convergence, enterprises should formulate provisions recall procedures, designate a person responsible for organizing and coordinating the recall and urge enterprises in accordance with the provisions of "drug recall management approach", drug once the post-marketing quality problems or injury event, to be the first time all the problems drug recall, to avoid new hazards. Adverse drug reaction monitoring, in the 1998 edition 高标准 relevant provisions in there, but the provision is very simple. In the new 高标准 enterprises should establish clearly defined adverse drug reaction reporting and monitoring and management system, the initiative to collect adverse reaction 高标准 content, and the establishment of specialized agencies, with full-time staff in charge of management. These provisions are being revised and will soon promulgate and implement the requirements of "adverse drug reaction reporting and monitoring management approach" is consistent. Correct understanding of the new 高标准 requirements of many pharmaceutical companies increasingly feel the new 高标准 certification path difficult. Among them, the medium and small pharmaceutical companies a significant portion of the production line less, the lack of regulatory changes in the risk profile, its plant design and regular upgrading work was not institutionalized provisions, which it must carry out the task of transformation caused by the long period before the new 高标准 deadline. However 高标准, facing the threat of loss of market shut down, rather than shut down the threat facing out. Kang Lihua think 高标准 management practices, drug manufacturers should correctly understand the new 高标准 requirements. In contrast, the new 高标准 more emphasis on software upgrade, is not necessarily going to tear down the old plant, the new plant reconstruction. In terms of hardware transformation, drug manufacturers should be combined with their own long-term development plan, considering the future production of new varieties and other factors, a comprehensive assessment and decision-making. Yangjiang 高标准, enterprises of the road, 高标准 content provided by enterprises in Huizhou City Road Enterprise Management Services Limited. Huizhou City, the rate of the Road Enterprise Management Services Ltd. (isoew.com) quality of service and products, continue to receive the recognition and trust of new and old customers and the industry. Our company is a certified member of the whole alliance network operators, business alliance customer service icon on the page, you can talk directly with our customer service staff, to our future cooperation happy!