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湖北医药企业严重违规GMP证书被收回 四家整改后重新发回
2017-08-22 10:43:43 中国青年网
人民网武汉8月22日电 2017年以来,湖北省食品药品监督管理局陆续发布一批收回和发回药品GMP证书公告。湖北潜江制药、一半天制药、康源药业、绿金子药业、中佳合成制药五家医药企业因严重违反《药品生产质量管理规范》,药品GMP证书被收回。潜江制药、一半天制药、康源药业、绿金子药业四家企业经整改检查后,GMP证书重新发回。
1月22日,湖北省食品药品监督管理局发布公告称,湖北潜江制药股份有限公司违反《药品生产质量管理规范》(2010年修订)规定,依据《药品生产监督管理办法》第五十五条和《药品生产质量管理规范认证管理办法》第三十三条规定,依法委托潜江市食品药品监督管理局收回其《药品GMP证书》。8月7日,湖北省食品药品监督管理局发布公告称,湖北潜江制药股份有限公司因严重违反《药品生产质量管理规范》(2010年修订),依法收回其《药品GMP证书》,并责令企业整改。经现场检查,该企业现已符合药品GMP要求,依据《药品生产质量管理规范认证管理办法》第三十四条规定,依法发回其《药品GMP证书》。此次发回的证书编号为CN20150016,发回证书范围是小容量注射剂(非最终灭菌)。
1月24日,湖北省食品药品监督管理局发布公告称,湖北康源药业有限公司严重违反《药品生产质量管理规范》规定,依据《药品生产质量管理规范认证管理办法》第三十三条规定,依法收回其《药品GMP证书》。6月19日,湖北省食品药品监督管理局发布公告称,湖北康源药业有限公司因严重违反《药品生产质量管理规范》(2010年修订),依法收回其《药品GMP证书》,并责令企业整改。经现场检查,该企业现已符合药品GMP要求,依据《药品生产质量管理规范认证管理办法》第三十四条规定,依法发回其《药品GMP证书》。此次发回的证书编号为:HB20140096,发回证书范围是合剂、糖浆剂、露剂、胶剂、煎膏剂、酊剂、口服溶液剂(含中药提取车间)。
4月1日,湖北省食品药品监督管理局发布公告称,湖北绿金子药业有限责任公司因严重违反《药品生产质量管理规范》(2010年修订),依法收回其《药品GMP证书》,并责令企业整改。经现场检查,该企业现已符合药品GMP要求,依据《药品生产质量管理规范认证管理办法》第三十四条规定,依法发回其《药品GMP证书》。此次发回的证书编号为:HB20160230,发回证书范围片剂、硬胶囊剂、颗粒剂、口服溶液剂、糖浆剂、原料药(胃蛋白酶、胃膜素、胰酶、硫酸软骨素钠、维酶素)(含中药提取车间)。此前,2016年12月23日,湖北省食品药品监督管理局发布公告称该企业严重违反《药品生产质量管理规范》规定,依据《药品生产质量管理规范认证管理办法》第三十三条规定,依法收回其《药品GMP证书》。
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