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目击利剑行动突查药品安全 76药企无一例违法--亲稳网络舆情监测室
2012-09-17
记者全程目击“利剑”行动突查药品安全 Reporters witnessed the whole"sword"Action raiding the drug safety
76家药企无一例违法生产 76 no one medicine enterprises illegal production
“现在是10点13分,到达康必得药厂”、“下午2点30分,离开药厂!”日前,本市启动代号为“利剑”的专项行动,对全市药品生产企业展开安全检查。记者随市药监局执法人员全程体验执法过程。有别于常规检查的是,本次执法检查全程隐蔽、到达离开时间第一时间汇报,更近似于一场测试药品安全监管能力的应急演练。
"It's ten o 'clock 13 points,Kang pharmaceutical factory will be arrived at"/"30 points 2 p.m.,From pharmaceutical factory!"a,This city start code for"sword"Special action,For the pharmaceutical production enterprise expansion safety inspection.Reporter with the city administration law enforcement personnel experience the whole process of law enforcement.Different from the routine inspection is,The law enforcement inspection the concealed/The first time to leave time report,The more similar to a test the supervision over drug safety ability of emergency drill.
行动当天确定检查范围 Action determine the scope of examination
9月13日上午8点多,各区县药监局突然接到市药监局的紧急视频会议通知,会议部署当天要在全市范围内抽查药品生产企业。
September 13, at 8 o 'clock,Various districts and counties, the administration's suddenly receive city, the administration's emergency video meeting notice,Meeting the deployment of the day in the selective examination within the scope of pharmaceutical production enterprise.
会议确定,将近两年发生违法案件多、群众举报多等较高风险企业和部分中药饮片生产企业列入重点检查范围。
Meeting to determine,Nearly two years will occur more than illegal cases/The masses to report such as much higher risk enterprise and part of Chinese medicine yinpian production enterprise included in the scope of inspection of key.
有无以化工原料替代合法原料药的违法行为、有无擅自委托加工药品或出租场地从事违法药品生产行为、有无生产假劣药品等违法行为,则被列入此次检查重点。
Have beyond chemical raw materials substitution legal API illegal behavior/Whether do STH without authorization processing drugs or rent site engaged in illegal drug production behavior/For the illegal activities such as the production JiaLie drugs,Is the key in check.
追溯系统现场测谎企业 Traceability system field polygraph enterprise
上午10点13分,记者随市药监局执法人员驱车来到位于大兴区的康必得药厂。这是一家以生产胶囊剂为主的药品生产企业。
13 points at 10 a.m.,Reporter with the administration's city law enforcement officers drove to is located in daxing OuDeKang shall be pharmaceutical factory.This is a production capsule primarily pharmaceutical production enterprise.
执法人员刚进厂就第一时间电话通报市局“到达检查时间”,并要求生产负责人出具今年生产的所有药品类、批次、原辅料供应商等资料。“通报到达离开时间,有演练的意思,看看哪些环节不足。”市药监局安监处副处长焦立功说。
Law enforcement personnel just entered factory is the first telephone bulletin factories"To check the time",And the production requirements issued by the production of this year all drug class/batch/Raw materials suppliers material."Reporting to leave time,Have the meaning of practice,See which link shortage."The city's drug watchdog safety supervision place place pair place telephoto observing said.
“你们胶囊壳供应商是哪?把供应商资质拿出来看看”、“你们现在药品品类有多少?有没有停产的?”执法人员一边翻阅资料一边问。
"You capsule shell which is the supplier?Take out the supplier qualification to see"/"You now how much drug category?Have the production?"Law enforcement personnel flicked through material side asked.
记者注意到,执法人员还从包里掏出了一份事先准备好的药品单,与企业提供的资料一一对比,“我们有个追溯系统,企业生产什么药,都能查到,对比主要目的是看企业有没有‘说谎’。”
Reporter noticed,Execute the law personnel also from the bag took out a prepared drugs single,And enterprises to provide data contrast one,"We have a traceability system,Enterprise production what medicine,Is to be found,Contrast the main purpose is to see enterprise have‘lying’."
查生产车间不漏一扇门 Check production workshop don't leak a door
在经过认真对照,做到“心中有数”后,执法人员分两路查看了企业生产车间和库房。经过两道严格的“更衣”程序后,记者也随执法人员进入了企业生产车间。这家企业总共有4个生产车间,普通类固体车间、激素类固体车间、外用制剂车间、口服液制剂车间。
After carefully controlled,do"Know fairly well"after,Law enforcement personnel points two way to check the enterprise production workshop and warehouse.After two strict"Change clothes"program,Reporters also along with law enforcement personnel to enter the enterprise production workshop.The enterprise has a total of four production workshop,General solid shop/Hormone solid shop/External preparation workshop/Oral liquid preparations workshop.
“全副武装”地行走在药品生产车间的滋味不太好受。记者原本以为检查很快就能结束,但与想象不同,4个车间总共有100多扇门,执法人员都一一推开,就连从门外一眼可见的清洁间也没放过。在每一部机器前、每一处堆放物品前、执法人员都停下来仔细检查,不断与工人核对名称、批号。4个车间的检查,执法人员一共用了两个多小时。
"Armed to the teeth"To walk in pharmaceutical production workshop taste not too well.Reporter thought check should be finished soon,But different and imagination,Four shop has a total of more than 100 door,Law enforcement personnel to push away,Even from outside the door one eye visible clean room also didn't pass.In each a machine before/Each place before placing objects/Law enforcement personnel all stop check carefully,Constantly and workers check the name/Batch number.Four workshop inspection,A common law enforcement personnel for more than two hours.
“检查主要目的是看有没有与生产药品不相关的原辅料,所以每个地方都要检查到位,这样才能确保每一粒安全药出炉。”走出车间,摘下口罩,有着11年工作经验的执法人员张亚东颇为欣慰地告诉记者,“车间没有问题!”
"Check the main purpose is to look have and production drug is not related to the raw materials,So every place to check in place,In order to ensure that each grain safety a medicine."Walked out of the shop,Took off mask,With 11 years working experience law enforcement personnel ZhangYaDong rather have the pleasure to tell reporter,"Shop no problem!"
未见违法生产药品行为 Did not see the illegal drug production behavior
市药监局、各区县药监局在当天进行的“利剑”行动中出动了200余人,经过9小时30分的突击奋战,突击检查了76家药品生产企业,未发现违法生产药品等行为,但部分企业存在管理环节不规范等问题。
City's drug watchdog/Each area county regulators on the day"sword"Action out of more than 200 people,After 9 hours of 30 points for assault,Assault examined 76 pharmaceutical production enterprise,Not found the illegal drug production, etc,But part of the enterprise exists the problems such as nonstandard management link.
据悉,本市共有250多家药品生产企业。下一步,药监部门还将不定期抽查,确保安全药生产。晨报记者 邹乐
It is reported,This city more than 250 home pharmaceutical production enterprise.The next step,Also department will also not regularly check,To ensure the safe medicine production.Morning paper reporter ZouLe
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