法国某公司EU GMP检查失败

20151030 法国某公司EU GMP检查失败  

法国CARGILL FRANCE  EU GMP失败，产品为非无菌原料药，不符合情况如下：
Nature of non-compliance : Overall, 14 observations were made,including 1 critical deficiency and 4 major deficiencies:
总共发现14个缺陷，包括1个关键项，4个主要项。
[Critical] The management of semi-finished batches and of the mixing operationswas deficient and conformity of the final batches to specifications, notablyPh.Eur. specifications, could not be guaranted.
【关键】半成品批次和混合担任有缺陷，不能保证最终批产品符合质量标准，特别是欧洲药典
[Major 1] The site had been manufacturing an active substance without ANSMauthorisation.
【主要1】现场曾未经ANSM批准生产一个原料药
[Major 2] The change control related to the suppression of one filtration stepin the active substance manufacturing process was deficient.
【主要2】原料药生产工艺中一个压滤步骤有关的变更控制有缺陷
[Major 3] The manufacturing of the active substance had not been made usingmaster production instructions and no batch production records had beenestablished.
【主要3】原料药生产未使用工艺规程，没有建立批生产记录
[Major 4] No review of batch production records of critical process steps hadbeen done before release of the active substance for distribution.
【主要4】在原料药放行销售前，没有对关键工艺步骤批生产记录进行审核
7 observations are related to lack of traceability, risks of contaminationinduced by the absence of cleanliness in the production environment, very badcondition of the production equipment and insufficient equipment cleaningprocedures. The inspection’s observations also apply to the manufacture ofpharmaceutical excipients and starting materials that are intended to be usedas ingredients in cosmetics and medical devices, which are manufactured underthe same conditions as the active substance.
7个缺陷与可追溯性缺乏、生产环境没有缺陷导致污染风险、生产设备条件很差、设备清洁程序不充分有关。检查人员发现的缺陷也存在于药用辅料和用于化妆品和医疗器械辅料生产的起始物料的生产中，这些物料是在与原料药一样的条件下生产的。

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