中新网9月19日电  据国家食药监局网站消息，日前，药监局召开会议部署加强无菌药品生产质量监管工作。药监局强调强化无菌保障措施，防止药品质量安全事件的发生。

Beijing on September 19 (Reuters)  According to the national food, the administration's web site message,a,The administration's meeting deployment strengthen aseptic drug production quality supervision work.The administration's emphasis on strengthening aseptic safeguard measures,To prevent the occurrence of drug quality and safety.

　　9月18日，国家食品药品监管局召开视频会议，部署加强无菌药品生产质量监管工作，各省级食品药品监管局领导及相关处室负责人参加了会议。会议对当前无菌药品生产的安全形势进行了深入分析，查找问题并制定措施。会议提出三点要求：

On September 18,,State food and drug supervision bureau held a video conference,The deployment of strengthen the aseptic drug production quality supervision work,The provincial food and drug supervision bureau leadership and related office chief attended the meeting.The meeting on the current aseptic pharmaceutical production safety situation to carry on the thorough analysis,Find problems and measures.The meeting proposed three requirements:

　　一要采取有效措施强化无菌药品生产企业质量监管，督促企业严格执行药品GMP有关规定，强化无菌保障措施，确保药品质量安全。

One should take effective measures to strengthen the aseptic pharmaceutical production enterprise quality supervision,Supervise and urge enterprise strictly implement the relevant provisions of the pharmaceutical GMP,Strengthen the aseptic safeguard measures,To ensure the quality and safety of drugs.

　　二要做好1998年版GMP与新修订药品GMP贯彻实施的相互衔接工作。督促药品生产企业严格按照经过验证的生产工艺和批量组织生产，保证新修订药品GMP实施工作的平稳、有序。

Secondly, to do 1998 edition GMP and the new revised drug GMP implementation of mutual connection work.Supervise the pharmaceutical producing enterprises in strict accordance with the validated production technology and batch production organization,Ensure that the new revised drug GMP implementation work smoothly/orderly.

　　三要加强对无菌药品生产企业贯彻实施新修订药品GMP工作的分类指导，推动无菌药品生产企业新修订药品GMP认证工作进展。

Third, we need to strengthen the aseptic pharmaceutical producing enterprises implement the newly revised drug GMP work classification guidance,Promote aseptic pharmaceutical production enterprise newly revised drug GMP authentication work progress.

　　近年来，药监局高度重视无菌药品质量监管，采取了提高质量标准、改进生产工艺、实施电子监管等多项有效的监管措施。同时，加强对相关企业和产品的监管和监测工作，对发现存在安全性问题的企业和产品及时采取有关措施，要求相关省局对企业开展现场检查、责令企业召回问题产品、督促企业停产查找原因，防止药品质量安全事件的发生。

In recent years,The administration's attaches great importance to aseptic drug quality supervision,Taken to improve quality standards/Improvement production process/Implementation of electronic supervision and so on many effective regulatory measures.At the same time,To strengthen the supervision of the relevant enterprises and products and monitoring work,Found on the safety problem of enterprises and products to take relevant measures,ShengJu requirements related to the enterprise to carry out on-site inspection/The enterprise shall be ordered to recall problem product/Supervise the enterprise production find the reasons,To prevent the occurrence of drug quality and safety.