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医药翻译网翻译了一份《CFDA发布药品质量公告(总第6期)》

2015-01-20|发布者: 373209447|


In December 29th, the State Administration of food and Drug Administration released the latest issue of drug quality bulletin (total sixth period), announced the quality inspection of Aciclovir Eye Drops, Paclitarel Injection, Guizhi Fuling pill, Lacidophilin Dispersible Tablets compound Yuxingcao tablets, such as 21 varieties of 3200 batches of the drug, and the inspection according to standards of 45 batches of the drug.

 

20141229日,国家食品药品监督管理总局发布了最新一期药品质量公告(总第6期),公布了对阿昔洛韦滴眼液、桂枝茯苓丸、紫杉醇注射液、乳酸菌素分散片、复方鱼腥草片等21个品种3200批药品的质量抽验情况,以及经查处不符合标准规定的45批次药品。

 

Be stable overall quality status of drug sampling and testing, but also exposed individual pharmaceutical producing enterprises has some defects in the production process control, sterility assurance level, individual enterprises continuous multi batch testing unqualified, reflects the quality of management of a few enterprises have serious defect. Some enterprises and units also exist some problems in the aspects of drug transport, storage and other conditions of security. Inspection found not meeting the prescribed standards of drug unqualified project mainly content determination and check in dissolution, microbial limit, related substances, pH value, moisture, acidity, visible foreign matter.

 

被抽验药品的总体质量状况稳定,但也暴露出少数药品生产企业在生产过程控制、无菌保障水平等方面存在一定缺陷,其少数企业连续多批次抽验不合格,反映出个别企业质量管理存在严重缺陷。部分企业和单位在药品运输、贮藏等条件保障方面还存在众多问题。抽验中发现的不符合标准规定药品的不合格项目主要有含量测定项和检查项中的溶出度、水分、酸度、微生物限度、有关物质、pH值、可见异物等。

 

The State Administration of food and drug administration has organized relevant province (area, city) food and drug supervision and Administration Department of the inspection found not meeting the prescribed standards of drugs taken the necessary control measures, according to the relevant provisions of the production enterprises and sampling units shall be investigated and dealt with. Anhui Province, Jilin province food and drug supervision and Management Bureau of Anhui has three super Pharmaceutical Co. Ltd. and Jilin Huifa pharmaceutical Limited by Share Ltd to make administrative punishment shall confiscate the illegal income and fine. At the same time requirements related enterprises and units to seriously check, in-depth investigation of reason and rectification, to eliminate hidden dangers, to ensure drug quality and safety.

 

国家食品药品监督管理总局已组织相关省(区、市)食品药品监督管理部门对抽验检查的不符合标准规定的药品采取了必需的控制措施,依据有关规定对生产企业和被抽样单位依法进行查处。吉林省、安徽省食品药品监督管理局已对吉林省辉南辉发制药股份有限和公司安徽三超药业有限公司做出没收违法所得和罚款的行政处罚。同时要求相关企业和单位认真检查,深入排查问题并进行整改,切实去除隐患,确保药品质量安全。



本文关键字:医药翻译  药品质量  药品质量翻译  药品质量公告  

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