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醫藥翻譯網翻譯了一份《CFDA發布藥品質量公告(總第6期)》

作者:醫藥翻譯   日期:2015-01-20   

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,國家食品藥品監督管理總局發布了最新一期藥品質量公告(總第6期),公布了對阿昔洛韋滴眼液、桂枝茯苓丸、紫杉醇注射液、乳酸菌素分散片、複方魚腥草片等21個品種3200批藥品的質量抽驗情況,以及經查處不符合標準規定的45批次藥品。

 

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.

 

被抽驗藥品的總體質量狀況穩定,但也暴露出少數藥品生產企業在生產過程控製、無菌保障水平等方麵存在一定缺陷,其少數企業連續多批次抽驗不合格,反映出個別企業質量管理存在嚴重缺陷。部分企業和單位在藥品運輸、貯藏等條件保障方麵還存在眾多問題。抽驗中發現的不符合標準規定藥品的不合格項目主要有含量測定項和檢查項中的溶出度、水分、酸度、微生物限度、有關物質、pH值、可見異物等。

 

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.

 

國家食品藥品監督管理總局已組織相關省(區、市)食品藥品監督管理部門對抽驗檢查的不符合標準規定的藥品采取了必需的控製措施,依據有關規定對生產企業和被抽樣單位依法進行查處。吉林省、安徽省食品藥品監督管理局已對吉林省輝南輝發製藥股份有限和公司安徽三超藥業有限公司做出沒收違法所得和罰款的行政處罰。同時要求相關企業和單位認真檢查,深入排查問題並進行整改,切實去除隱患,確保藥品質量安全。



本文關鍵字:醫藥翻譯  藥品質量  藥品質量翻譯  藥品質量公告  

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