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转载于Julia博客
近期一家中国工厂欧盟检查失败
数据来源：http://eudragmdp.ema.europa.eu/inspections/gmpc/searchGMPNonCompliance.do
检查单位：德国下萨克森—奥尔登堡州药监
受检查单位：浙江普洛康裕生物制药有限公司
地址：Geshan IndustrialZone, Dongyang, 322109, China
检查日期：2014-10-29
检查失败产品：硫酸粘菌素、粘菌素、酒石酸泰乐菌素
不符合事项：1个关键项、1个重大项、若干个轻微项。关键项是在对化验室检查过程中发现的。公司未能建立程序来识别和验证与GMP相关的计算机系统。2批硫酸粘菌素的分析报告被证明为捏造。HPLC图谱被从之前的批次拷贝过来重新命名，给定新批号和文件名称。几个电子存贮的HPLC走样信息没有进入仪器的日志。这些数据的来源最后无法澄清。单个工作站和中央服务器均受没有到充分的保护，不能保证数据的删除和修改受到控制。工作站和服务器之间的数据转移显示出来是不完整的。没有审计追踪，没有一致性检查来防止数据误用。
NCA行动建议：建议禁止其销售。
备注：尽管实际所发现的数据仅为1个化验员所操作的（29批中）2个批次的分析记录，仅影响硫酸粘菌素，但违规的程度无法精确界定。针对该问题，公司进行了专家调查和风险评估，得到结论没有发现更多批次受影响。公司将总体质量风险等级划为低。在检查过程中，InphA GmbH Bremen (下萨克森州的官方化验室)对2批中部分留样进行了检查和分析，HPLC对组分和有关物质项目的测试结果符合质量标准。
Trade and Industry Inspection Agency of State of Lower Saxony – Oldenburg
Report No : DE-NI-04-20141029
STATEMENT OF NON-COMPLIANCE WITH GMP
The competent authority of Germany confirms the following:
The manufacturer : Zhejiang Apeloa Kangyu Bio-Pharmaceutical Co. Ltd.
Site address : Geshan IndustrialZone, Dongyang, 322109, China
DUNS Number : 52-820-8528
From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2014-10-29 , it is considered that it does not comply with the Good Manufacturing Practice requirements referred to in
· The principles of GMP for active substances referred to in Article 51 of Directive 2001/82/EC
Manufacture of active substance. Names of substances subject to non-compliant :
COLISTIN SULFATE ( en ) / COLISTINE (SULFATE DE) ( fr )
[ 41401-7/8-3 ] TYLOSIN TARTRATE ( en )
Nature of non-compliance : The inspection identified one critical, no major and several minor deficiencies to EU GMP Guide Part II. The critical deficiency was found during inspection of the quality control laboratories. The company failed to establish a procedure to identify and validate GMP-relevant computerized systems in general. Two batch analysis reports for Colistin Sulfate proved to be manipulated. HPLC chromatograms had been copied from previous batches and renamed with different batch and file names. Several electronically stored HPLC runs had not been entered into the equipment logbooks. The nature of these data could not finally been clarified. Neither the individual workstation nor the central server had been adequately protected against uncontrolled deletion or change of data. The transfer of data between workstations and server showed to be incomplete. No audit trail and no consistency checks had been implemented to prevent misuse of data.
Action taken/proposed by the NCA :
Prohibition of supply
Due to the nature of non-compliance prohibition of supply is recommended
Additional comments : Although data manipulation was actually observed only in 2 (out of a total of 29) reviewed batch analysis records from one operator and affected Colistin Sulfate batches only the extent of the violation cannot be delimited precisely. The company performed ad hoc investigation and risk assessment on the issue and came to the conclusion that no evidence for further affected batches could be found. The overall quality risk was rated to be low by the company. Parts of the reserve samples of the two batches with the manipulated batch anlaysis records were taken during the inspection and analysed by the InphA GmbH Bremen (OMCL of Lower Saxony). The results of the HPLC testing on composition and related substances met the specification.
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发表于 2014-12-26 09:48:28
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