印度HREBS和JP欧盟检查失利

julia朱玉姣

至此，本年度公布的欧盟GMP检查失利印度生产商已增至6家，超过中国5家成为第一。

另外，本年度上半年还未过完，数据库中GMP检查失败记录已达20条，超过2015年全年的15条。鉴于各国GMP水平并无降低的前提，欧盟GMP检查力度确实相比有加强趋势。

数据来源：http://eudragmdp.ema.europa.eu/inspections/displayWelcome.do

检查方：意大利药监

检查时间：2016-3-11

公司名称：KREBS BIOCHEMICALS & INDUSTRIES LTD, Plant Unit II

受检地址：Kothapalli Village, Kasimkota Mandal, Visakhapatnam, AndhraPradesh, 531 031, India

原料药：SIMVASTATIN

Natureof non-compliance : 24 deficiencies were identified in total.Five of them were classified as major. The combination of the findingsdemonstrated a critical risk to public health, as the weaknesses of thecompany’s quality management system and the approach in several GMP areas suchas facilities, material management, quality of the water used in the productionand QC tests, were not robust enough to sustain a GMP compliant level. The fivemajor deficiencies were identified in the following areas:

不符合情况：总共发现24个缺陷。其中5个为主要。所有缺陷在一起证明对公共健康具有严重风险，因为公司质量管理体系薄弱，几个GMP方面所用方法，如设施、物料管理、生产用水质量和QC检测不够扎实，无法维持GMP符合水平。5个主要缺陷是关于以下方面：

•One in deviation management; 一个关于偏差管理

•One in personnel training; 一个关于人员培训

•One in facilities; 一个关于设施

•One in finished product storage management; 一个关于成品存贮管理

•One in production and monitoring of purified water. 一个关于生产和纯化水监测

Action taken/proposed by the NCA : NCA所采取的措施或建议的措施

Recall of batches already released 已放行批次的召回
Eachinvolved NCA should evaluate, following assessment conducted in conjunctionwith MAHs, if a recall of medicinal product is needed. Evaluation should takeinto account if there are alternative suppliers and potential risk of shortage.Given the nature of non-compliance, assessment should include a complete retestof all imported batches of active substance.

每个涉及的NCA均应进行评估，与MAH一起进行评估之后，如果需要的话则应召回。评估时应考虑是否有其它可替代供应商和潜在缺货风险。考虑到不符合情形，评估中应包括对所有进口的原料药批次进行复测。

Prohibition of supply 禁止供应
Prohibition of supply is recommended, unless there are not alternativesuppliers and there is a risk of shortage.

建议禁止供应，除非没有其它供应商，有缺货风险。

Suspension or voiding of CEP (action to be taken byEDQM)

CEP搁置或撤销（由EDQM采取措施）
Assessment of the findings of the EDQM inspection is currently on going: allCEP's suspension recommended by the inspection team was officially endorsed bythe Ad Hoc Committee on 30 March 2016.

对EDQM检查中发现缺陷的评估正在进行：检查团队建议搁置所有于2016年3月30日正式发放的CEP。

Others 其它
This supplier should not be approved in any new/ongoing application.

该供应商在新的和正在审批中的申报里不应被批准。

J P LABORATORIES PRIVATE LIMITED Block A-76

M.I.D.C. Chemical Zone Kurkumbh, Pune District, Daund,Maharashtra, 413801, India

检查时间：2016-3-16

检查方：意大利药监

原料药：ISOSORBIDEMONONITRATE, DILUTED (80% IN LACTOSE)

Nature ofnon-compliance : 28 deficiencies were raised by theinspectors, 9 of them c

lassifiedas “Major” in the following areas:

不符合项：检查官发现28个缺陷，其中9个为主要缺陷，在以下领域

-       Qualitymanagement质量管理

-       integrityand security of data in the quality system (1); 质量体系数据完整性和安全性（1）

-       Personnel(2) 人员（2）

-       Buildingand facilities (1) 建筑和设施（1）

-       Materialsmanagement (1) 物料管理（1）

-       Productionand In-Process control (1) 生产和中控（1）

-       Laboratorycontrol实验室控制

-       integrityand security of analytical data (1); 分析数据完整性和安全性（1）

-       Validation:equipment qualification (1) 验证：设备确认（1）

-       Changecontrol (1) 变更控制（1）

Theextent and severity of the findings, in combination with the repeated negativeinspection outcome, demonstrates the inability of the company to sustain anacceptable GMP compliance level, and constitutes a critical risk for publichealth.

缺陷的程度和严重性，与重复的负面检查结果一起，证明公司不能维持可以接受的GMP符合性水平，对公众安全构成关键风险。

Action taken/proposed by the NCA :

Recall of batches already released 已放行批次召回

Each involved NCA should evaluate, followingassessment conducted in conjunction with MAHs, if a recall of medicinal productis needed. Evaluation should take into account if there are alternativesuppliers and potential risk of shortage. Given the nature of non-compliance, assessmentshould include a complete retest of all imported batches of active substance.

Prohibition of supply 禁止供应

Prohibition of supply is recommended, unless there arenot alternative suppliers and there is a risk of shortage.

建议禁止其供应，除非没有其它供应商，有缺货风险。

Suspension or voiding of CEP (action to be taken byEDQM)

CEP搁置或撤销（由EDQM采取措施）

CEP was withdrawn. 撤销CEP。

Others 其它
The observed deficiencies are considered to apply to all other activesubstances manufactured at the same site (Isosorbide Mononitrate Pure,Isosorbide Mononitrate Diluted 90%, Isosorbide Mononitrate Diluted 70% ,Isosorbide Mononitrate Diluted 60%, Isosorbide Mononitrate Diluted 50%,Isosorbide Mononitrate Diluted 40% , Isosorbide Mononitrate Diluted 20%,Isosorbide Mononitrate Diluted 25%, Isosorbide Dinitrate Diluted 40%,Isosorbide Dinitrate Diluted 25%).

所发现的缺陷也涉及到在相同工厂生产的其它活性物质。

syhorchid

还是印度阿三牛

孙志勇_CRHoo

现在能过FDA太不正常了  不过就太正常了