Pursue and follow and produce supervising online Promote the safety coefficient of risky medicines in Heilongjiang

Pursue and follow and produce supervising online Promote the safety coefficient of risky medicines in Heilongjiang
Pursue and follow and produce supervising online Promote the safety coefficient of risky medicines in Heilongjiang
One day in October of this year, the early warning platform of quality safety risk of medicines of medicines supervision bureau of Heilongjiang Province food monitors some medicines toxic raw materials supplier's qualification of manufacturing enterprise to exceed the term of validity, applying to permit newly. This office requires enterprises before the supplier has not obtained the new licence by way of warning immediately, can't buy this toxic raw materials from it, thus prevent enterprise raw materials from being purchased unstandardly. In recent years, Heilongjiang Province office, around guaranteeing this safe centre of medicines, is exploring constantly that innovates manufacturing enterprise and variety supervision mechanism of risky medicines, verify key links effectively, stress the source is prevented, improve the prewarning of risk, have made the obvious effect. There are injectable preparation 48 manufacturing enterprises of medicines in all in Heilongjiang Province, 904 medicines varieties of injectable preparation. In 2007 - 2009, Heilongjiang Province office finishes injectable preparation medicines production technology and prescription to all normal production to verify. In order to understand the production process of each of injectable preparation medicines in detail, does not miss the hidden danger of any quality of the production ink, this office expects carrying on real-time supervision from the raw materials neck in the whole course of product inspection to each of injectable preparation medicines. How long namely a piece of medicines is produced to take, how long the inspector checks. Check the way through this kind, this office has found and dispelled the quality potential safety hazard in a large number of injectable preparation production of medicines, have delayed having medicines production in 17 varieties and 24 authentication codes such as E skill oil parenteral solution of the potential safety hazard, involve 13 enterprises. Combine and verify live, Heilongjiang Province office implements the situation of medicines GMP and follows the inspection to enterprises in an all-round way, the safe enterprise quality certification system of medicines of impact on directness carries on the assessment, have got rid of a large number of potential safety hazards of quality control link. Last year, this office found it was relatively general that the medicines manufacturing enterprise used Twain - 80 to make and increase the situation of the solvent, and our country has Twain - 80 as the security consumption standard of adjuvants of injectable preparation. Comment on security for science, the institute for drug control of Heilongjiang Province has promoted the research of relevant project, find Twain - 80 toxic power differences appear in injectable preparation of different propertiesing are prominent, it have as medicine in coordination with or inhibitory activity,therefore can't last medicines security consumption according to its briefly. In view of the above, Heilongjiang Province office stops production to deal with to injectable preparation medicines with potential safety hazard, prevent the occurrence of bad incident, agree to go on and produce in using Twain - 80 medicines with higher security at the same time. Heilongjiang is that traditional Chinese medicine injectable preparation is saved, there are injectable preparation manufacturing enterprises of 23 of traditional Chinese medicine big, 21 traditional Chinese medicine injectable preparation varieties, varieties such as injectable preparation of a pair of the rhizome of Chinese goldthread among them, stinging five plus injectable preparation, root of red-rooted salvia injectable preparation,etc., it is a traditional advantage variety inside the province, it is more risky varieties of serious bad reaction too. In order to guarantee the quality of production of traditional Chinese medicine injectable preparation, Heilongjiang Province office sets up from 2007 onlinely with producing and supervising and inspecting the mechanism, namely expect from the enterprise neck that makes the finished product, the supervisor supervises and inspects in the whole journey on the production line. Through this way, the supervision department has found and dispelled a large number of medicines potential safety hazards in time, have improved enterprise's production quality control and risk control level. In addition, drew workshop and preparation workshop and divided the situation in different districts and cities according to some traditional Chinese medicine injectable preparation manufacturing enterprises inside the province, this office has also set up the injectable preparation three sides of traditional Chinese medicine to link the supervision mechanism in the whole province, it draw traditional Chinese medicine, produce at preparation by ground supervision department and province office information communication, grasp the actual conditions of each production ink in time, prevent safe risk of medicines. In June of this year, Heilongjiang Province office prints and distributes <>,Through setting up medicines quality safety risk assessment mechanism and mathematical model, supervise message and go on quantizing and data processing to medicines that are obtained through many channels, realize the digitization of risk assessment. Monitor the prewarning of platform through the risk, produce potential safety hazard and risk to " find medicines early, control early, dispel early " ,Have reduced the incidence of the bad incident of production ink of medicines greatly.


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