药械

订阅

MedSci主页 / 所有栏目 / 药械

惊讶，著名药企GMP证书被回收！

2014-11-18 佚名 赛柏蓝

GMP证书

11月15日，国家食药监总局的官方网站发布两则消息。其一是： 2014年11月4日至5日，总局联合地方食药监局对吉林省四家生产肺宁颗粒药品生产企业开展了飞行检查，发现修正药业集团股份有限公司（柳河厂区）原料库存放的用于生产肺宁颗粒的药材返魂草部分发生霉变变质，企业还存在故意编造虚假检验报告等行为。 上述行为已严重违反《药品管理法》和药品GMP相关规定。目前，总局已要求吉林省局依法收回其药品

11月15日，国家食药监总局的官方网站发布两则消息。其一是：

2014年11月4日至5日，总局联合地方食药监局对吉林省四家生产肺宁颗粒药品生产企业开展了飞行检查，发现修正药业集团股份有限公司（柳河厂区）原料库存放的用于生产肺宁颗粒的药材返魂草部分发生霉变变质，企业还存在故意编造虚假检验报告等行为。

上述行为已严重违反《药品管理法》和药品GMP相关规定。目前，总局已要求吉林省局依法收回其药品GMP证书，并对该企业的违法违规行为严肃查处。

其二是，经国家评价性抽验发现，广东怡康制药有限公司生产的抗骨增生片（批号为120201）检出微量解热镇痛类抗炎药。2014年10月28-29日，总局联合地方食药监局对广东怡康制药有限公司等企业开展飞行检查。

经检查发现，该产品委托韶关市居民制药有限公司生产，通过对韶关市居民制药有限公司的延伸检查，查实该企业在生产过程中抗骨增生片与氯芬黄敏片发生交叉污染。这是一起典型的承接多家委托生产，中西药生产交替共线进行，清场不彻底造成的药品污染事件。

上述行为已违反《药品管理法》和药品GMP相关规定。目前，广东省局已依法收回广东怡康制药有限公司和韶关市居民制药有限公司药品GMP证书，案件正在进一步查处过程中，涉事产品已启动召回措施。

据统计，全国今年被回收的GMP证书至少已经达到37张。

评论区 (3)
#插入话题
  1. [GetPortalCommentsPageByObjectIdResponse(id=2042131, encodeId=c879204213136, content=<a href='/topic/show?id=2e2c8136ad' target=_blank style='color:#2F92EE;'>#GMP证#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=70, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8136, encryptionId=2e2c8136ad, topicName=GMP证)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=25e7304, createdName=snf701207, createdTime=Sat May 30 13:08:00 CST 2015, time=2015-05-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=12726, encodeId=356312e2659, content=著名药企也是垃圾, beContent=null, objectType=article, channel=null, level=null, likeNumber=117, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo7ceOChkqicg6SzjqymjoEtLx55A9HNpmV1quNDdicpmTPZp1WXCq35u64iaCjRhibmrEPN5JHdvOZt9Ajj4MxzLbJ9/0, createdBy=ddf3111026, createdName=jawel, createdTime=Thu Nov 27 21:10:00 CST 2014, time=2014-11-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1376681, encodeId=c3d813e668147, content=<a href='/topic/show?id=30488132aa' target=_blank style='color:#2F92EE;'>#GMP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=79, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8132, encryptionId=30488132aa, topicName=GMP)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8c6f389, createdName=hxq78316, createdTime=Thu Nov 20 00:08:00 CST 2014, time=2014-11-20, status=1, ipAttribution=)]
    2015-05-30 snf701207

    #GMP证#

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=2042131, encodeId=c879204213136, content=<a href='/topic/show?id=2e2c8136ad' target=_blank style='color:#2F92EE;'>#GMP证#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=70, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8136, encryptionId=2e2c8136ad, topicName=GMP证)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=25e7304, createdName=snf701207, createdTime=Sat May 30 13:08:00 CST 2015, time=2015-05-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=12726, encodeId=356312e2659, content=著名药企也是垃圾, beContent=null, objectType=article, channel=null, level=null, likeNumber=117, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo7ceOChkqicg6SzjqymjoEtLx55A9HNpmV1quNDdicpmTPZp1WXCq35u64iaCjRhibmrEPN5JHdvOZt9Ajj4MxzLbJ9/0, createdBy=ddf3111026, createdName=jawel, createdTime=Thu Nov 27 21:10:00 CST 2014, time=2014-11-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1376681, encodeId=c3d813e668147, content=<a href='/topic/show?id=30488132aa' target=_blank style='color:#2F92EE;'>#GMP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=79, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8132, encryptionId=30488132aa, topicName=GMP)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8c6f389, createdName=hxq78316, createdTime=Thu Nov 20 00:08:00 CST 2014, time=2014-11-20, status=1, ipAttribution=)]
    2014-11-27 jawel

    著名药企也是垃圾

    0

  3. [GetPortalCommentsPageByObjectIdResponse(id=2042131, encodeId=c879204213136, content=<a href='/topic/show?id=2e2c8136ad' target=_blank style='color:#2F92EE;'>#GMP证#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=70, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8136, encryptionId=2e2c8136ad, topicName=GMP证)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=25e7304, createdName=snf701207, createdTime=Sat May 30 13:08:00 CST 2015, time=2015-05-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=12726, encodeId=356312e2659, content=著名药企也是垃圾, beContent=null, objectType=article, channel=null, level=null, likeNumber=117, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo7ceOChkqicg6SzjqymjoEtLx55A9HNpmV1quNDdicpmTPZp1WXCq35u64iaCjRhibmrEPN5JHdvOZt9Ajj4MxzLbJ9/0, createdBy=ddf3111026, createdName=jawel, createdTime=Thu Nov 27 21:10:00 CST 2014, time=2014-11-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1376681, encodeId=c3d813e668147, content=<a href='/topic/show?id=30488132aa' target=_blank style='color:#2F92EE;'>#GMP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=79, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8132, encryptionId=30488132aa, topicName=GMP)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8c6f389, createdName=hxq78316, createdTime=Thu Nov 20 00:08:00 CST 2014, time=2014-11-20, status=1, ipAttribution=)]
    2014-11-20 hxq78316

    #GMP#

    0