Lacking and improving the quality system causes" Medicine is hurt " Constant

Lacking and improving the quality system causes" Medicine is hurt " Constant
Lacking and improving the quality system causes" Medicine is hurt " Constant
" guarantee the quality, curative effect and system in need of one set is completing of security of medicines are ensured " ,Chinese the intersection of foreign-investment enterprise and the intersection of association and medicines develop and develop the trade committee (RDPAC) The intersection of executive president and Liu ZhenXian Mr. point out in carry on in the research finding to leading the intersection of pharmacy and enterprise, quality of China, "the system need, contain the intersection of raw materials and purchase until the intersection of patient and the whole course that medicine warn behind the administration at source, only depend on that it is unable to guarantee the quality of medicines and security to examine. " A few days ago, RDPAC, U.S.A.'s pharmacy research and manufacturer's association (PhRMA) Trust Ann jointly company analyze the systematic assessment to enterprise's quality system, pharmacy of China, forever, release " the pharmacy enterprise's quality system survey and study event " the report. Current situation: Authorize with obtaining GMP, the quality of medicines stills have greater differences that assess the activity this time, it is mainly research which are for 13 leading persons who are correlated with with a large number of trade interests of pharmacy enterprise, including Pfizer, Bayer, A Slay health, Bayer, gift coming 8 overseas-funded enterprise and Zhejiang sea, Beijing be set up strong ining 5 enterprises domestic-investment to be filled by departmented, Shenzhen in. RDPAC the intersection of hygiene and economic Chen Yi Dr., director of affairs, introduce, through finding, GMP (fine to make the standard) likewise Approved qualified pharmacy enterprises, because of the difference of management systems of quality, there may be greater differences in the quality of medicines. This problem was once happening " Medicine hurts the incident " China is particularly obvious, " two neat medicines " , " happy " , " purine of butterfly of first ammonia of Shanghai Hua Lian " In the incident, involve in thing enterprises to all authorize through national GMP. The same the intersection of composition and medicines, craft different side effect have difference see the factory off qualified medicines too, it is only a beginning. Chen Yi introduces, everybody can see that has enumerated dozens of kinds even possible bad reaction of more than one hundred kinds on the manuals of some medicines, even further increase the possibility revised after listed; Proves only in a nutshell that but some other medicines exactly the same as this chemical name can have something to do. This can not prove the former's quality is not so good as the latter, has proved instead the former carries on exhaustive clinical research before being listed, and improve medicines and warn the system. Understanding the information only in an all-round way, doctors could assess risks and incomes of drug therapy rationally, thus the treatment most suitable for the patient decides. "It warns the system to need enterprise's enormous input to set up complete medicine, some number in the safe group of the whole world medicine of large-scale pharmacy enterprise reaches thousands of people. Someone will think since the composition of medicines is the same, that bad reaction and side effect should be the same, but because of the difference between craft and quality system, even if is the medicine of the same composition, its bad reaction will have certain difference too, so it needs to set up complete medicine and warning the system to model medicine enterprises. " Chen Yi says in this way. Propose: All of us like trying the goods chosen in person when buying goods such as electric apparatus, clothes,etc. to establish the system of complete quality, through the appearance, can be used etc. normally to judge the quality of the products, in fact have quality testing personnel to examine them one by one before these goods are dispatched from the factory, so as to ensure the quality of the goods. Chen Yi says, but we are unable to examine each of medicines alone, can only offer and roughly judge one of medicine quality of a certain batch to inspect by random samples. So the old happy foundation, this report, proposes, can't totally guarantee the lasting stability of the quality of medicines to examine only to the medicines finished product composition, the quality of medicines is produced out, do not measure out. So a set of complete quality systems are essential; Secondly, it sees factories off to be only one beginning qualified medicines, medicines the intersection of quality and guarantee should run through, merchandize whole lifespan that use to medicines producing. South Daily reporter Lee


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