必赢亚娱乐官网(中国)有限公司

您当前位置:奥咨达医疗器械服务集团 >> 资讯中心 >> 行业信息 >> 浏览文章

【奥译言】FDA警告中国API制造商数据完整性问题

阅读: 2017年06月26日

【奥译言】FDA警告中国API制造商数据完整性问题


美国食品和药物管理局(FDA)周一公布了一封警告信,是关于去年底检查河北省设施时发现的活性药物成分(API)制造商秦皇岛紫竹药业的数据完整性问题。

   背     景    

3月份,由于企业是紧急避孕药左炔诺孕酮唯一一家资格预审的API供应商,因此,由于检查结果,FDA将秦皇岛作为进口警报提出上诉,该举措引起了世界卫生组织(WHO)的警觉。该企业也被世卫组织资格认证,为其他两种避孕药米非司酮和炔雌醇提供API。


据世卫组织先容, 2015年检查秦皇岛紫竹药业发现五大缺陷,包括数据完整性问题。虽然企业为缺陷提供了纠正和预防措施(CAPA)后检查合格。


世卫组织指出,尚未收到关于左炔诺孕酮质量问题的报告,采购机构可以继续购买含秦皇岛紫竹药业的API的成品药物,该机构表示计划对该企业工厂进行后续检查确定左炔诺孕酮API的替代来源。


  FDA警告信    

现在,FDA的警告信揭露了导致进口警报的问题。


据FDA先容,秦皇岛紫竹药业员工通过覆盖测试结果和运行重复测试来操纵其高效液相色谱(HPLC)系统的测试结果,直到达到理想结果


FDA写道,“在检查过程中,分析师承认由于未知原因,将时钟重新设置并重复分析,”并且该企业仅报告了重复测试的结果。


FDA还表示,该企业已在该设施的七个HPLC系统上禁用了审计跟踪功能。


FDA调查人员表示,他们发现批量生产记录缺少制造数据,日期和签名。其中一项,调查人员说,他们发现企业质量保证部门的粘滞便笺,指示操作人员如何填写缺失数据,来说明一批未经过质量认证但最终用于制造的原料。

原文出处:http://www.raps.org/Regulatory-Focus/News/2017/06/21/27952/FDA-Warns-Chinese-API-Maker-for-Data-Integrity-Issues/

奥咨达服务


FDA 510K 申报服务和周期(含工厂注册和合同范围内产品列名)
FDA De Novo
FDA MD 预提交(Pre-submission)申报服务和周期
FDA PMA申报服务和周期
FDA产品列名 申报服务和周期
FDA豁免510K-服务


英语原文  


FDA Warns Chinese API Maker for Data Integrity Issues


Posted 21 June 2017 By Michael Mezher


The US Food and Drug Administration (FDA) on Monday released a warning letter sent to active pharmaceutical ingredient (API) maker Qinhuangdao Zizhu Pharmaceutical for data integrity issues uncovered during an inspection of its Hebei province facility late last year.


Background


In March, FDA placed Qinhuangdao on import alert as a result of the inspection findings, an action that raised alarms at the World Health Organization (WHO), as the company is the only prequalified API supplier for the emergency contraceptive levonorgestrel. The company is also prequalified by WHO to supply API for two other contraceptives, mifepristone and ethinylestradiol.


According to WHO, its 2015 inspection of Qinhuangdao's facility turned up five major deficiencies, including data integrity issues, though the inspection was "closed as compliant" after the company provided corrective and preventative actions (CAPAs) for the deficiencies.


While WHO notes that it has not received any reports relating to quality issues for levonorgestrel and that procurement agencies can continue to purchase finished drugs that contain APIs made by Qinhuangdao, the agency said it is planning a follow-up inspection of the facility and is looking to identify alternative sources for levonorgestrel API.


FDA Warning Letter


Now, FDA's warning letter sheds light on the issues that prompted the import alert.
According to FDA, Qinhuangdao employees manipulated test results from its high performance liquid chromatography (HPCL) systems by overwriting test results and running repeat tests until the desired results were achieved.


"During the inspection your analysts admitted to setting the clock back and repeating analyses for undocumented reasons," FDA writes, adding that the company only reported passing results from the repeated tests.


FDA also says the company had disabled the audit trail feature on seven of the HPLC systems at the facility.


FDA investigators also say they found batch production records that were missing manufacturing data, dates and signatures. In one instance, the investigators say they found sticky notes from the company's quality assurance department on batch records that instructed operators to fill in the missing data for a batch of starting material that ultimately went on to be used in manufacturing without being approved by the quality unit.




内容来自:RAPS

整理翻译:奥咨达


FDA 510K 申报服务和周期(含工厂注册和合同范围内产品列名)
FDA De Novo
FDA MD 预提交(Pre-submission)申报服务和周期
FDA PMA申报服务和周期
FDA产品列名 申报服务和周期
FDA豁免510K-服务



奥咨达翻译服务

奥咨达翻译团队根植于中国,面向全球,专注为医疗器械领域的企业提供专业、高效的翻译解决方案。翻译领域包括医疗器械的研发、注册、临床、上市后监督、营销、管理、培训等,译稿已涵盖医疗器械领域的所有类型。


奥咨达翻译组联系方式:

邮箱:trans@osmundacn.com




(编辑:佚名 来源:E药经理人)
分享按钮:
上一篇:一张图看懂新材料产业规划
下一篇:【奥译言】临床试验的创新思路--移动技术的应用

常用查询

    评审进度查询       |         医疗器械标准目录库       |         临床试验机构目录库       |         检测中心承检目录库

    医疗器械分类目录      |       医疗器械检测中心受检目录      |      国产必赢亚娱乐官网查询      |       进口必赢亚娱乐官网查询

更多>>

专家解读

奥咨达服务项目流程

临床试验
体外诊断试剂
进口注册
中国注册
质量管理体系
医械咨询
欧盟CE认证
美国FDA注册
海外注册
  • 经验丰富

    3000+医械客户,标准服务

  • 安全保障

    签订业务合同,资料专人管理

  • 合作无忧

    200+专业顾问,保质完成服务

  • 信誉卓著

    高新技术企业,信誉保障

  • 必赢亚娱乐官网|必赢亚娱乐官网

    XML 地图 | Sitemap 地图