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公司名称：Medreich Limited—Unit V 受检地址：Plot No.45 A&B, Anrich Industriel Estate, Bollaram, MedakDistrict, Andra Pradesh, 502325, India 检查日期：2014-5-16 检查方：法国药监 Nature of non-compliance : 58 deficiencies have been raised during the inspection which was afollow-up of the inspection conducted from 28 January 2013 to 1 February 2013(see NCR/HPF/FR/1/2013). 1 deficiency related to data falsification has beenclassified as "critical" . 29 deficiencies have been classified as"major". Among them, - 5 were related to poor level of qualitymanagement (inadequate deviations management system with no exhaustive record,no classification and no thorough investigation), - 3 were related to personnel(no formal policy on temporary workers specially for quality criticalactivities such as visual inspection), - 5 were related to the maintenance ofequipment (depyrogenisation tunnel and RABS used for the filling operation, LAFused for the sampling of sterile starting materials ...), - 4 were related todocumentation (documentation management and data integrity with difficulty todemonstrate that the actions recorded were genuine), - 9 were related toproduction (sterile and non-sterile products) including risk of crosscontamination, poor visual inspection process handling, poor in-process controlhandling (weight of vials, weight of tablets and hard capsules), poor handlingof broken vials issues. **************************************** 不符合情况：检查中发现了58个缺陷，本次检查是2013年1月28号至2月1日检查的跟踪检查（参见NCR/HPF/FR/1/2003）。 1个缺陷关于数据假造，被判定为“关键”缺陷。 29个缺陷被判定为“主要缺陷”。 其中，5个是关于质量管理水平差（偏差管理系统不充分，没有全面记录，没有分级没有彻底调查）。 3个是关于人员（没有正式的临时工人方针，尤其是质量关键活动，如目视检查） 5个是关于设备维护（除热源隧道和RABS用于灌装操作。LAF用于无菌起始物料的取样……） 4个是关于文件记录（文件记录管理和数据完整性难以证明所记录的动作是真实的） 9个是关于生产的（无菌和非无菌产品）包括交叉污染的风险，目视检查过程处理太差，中控处理太差（小瓶重要、片剂重要和硬胶囊）、破碎小瓶问题处理差 update: ANSM received a comprehensiveaction plan that addresses the issues raised during the inspection. This actionplan was reviewed and was found acceptable. However, due to the absence of anynational product on the French market and the absence of any pendingapplication involving this site, ANSM will not perform a follow-up inspectionof this site to ensure the effective implementation of this action plan. 更新：ANSM已经收到全面的措施计划，说明了检查期间发现的问题。此措施计划经过审核，认为可以接受。但是，由于在法国市场没有任何的国家药品上市，也没有牵涉到该工厂的任何正在审核的申报。ANSM因此将不会对此工厂进行跟踪检查来确保此措施计划的有效实施。
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