EUGDMP数据：印度PARABOLIC DRUGS LIMITED 欧盟检查失败

EUGDMP数据：印度PARABOLIC DRUGS LIMITED 欧盟检查失败  

2015-07-29 11:30:09

检查方：意大利
检查日期：2015-6-17
检查地址：

PDL-2, Plot No. 45, Industrial Area, Phase II, Panchkula District, Haryana, 134 113, India

检查品种：DICLOXACILLIN SODIUM原料药
不符合情况：发现质量管理体系严重失控，在下列领域发现的关键和重大偏差表明所有EU-

GMP

要求的“原则”均存在缺陷（除了2.13和2.14外）：文件、样品和物料保存和控制不充分、伪造文件和数据、QC化验室数据完整性和数据安全、变更控制、偏差管理和风险管理。
总共发现27个缺陷：
3个关键：文件管理体系、做假、数据安全和完整性
7个主要缺陷分布在QC、人员、文件记录和变更控制
Nature of non-compliance : The quality management system was found to be seriously uncontrolled and deficient in all “Principles” (except principle 2.13 and 2.14) reported in the EU- GMP requirements as evidenced by critical and major deviations found in the following areas: inadequate storage and control of documents and samples and material, falsification of documents and data, integrity and security of data in the QC laboratory, Change Control, Deviations management and Risk management. In total 27 deficiencies were found: 3 classified as Critical were found in the area of Documentation management system, Falsification and Security and integrity data; 7 classified as Major deficiencies were found in the area of QC, Personnel, Documentation and Change Control.

其CEP将被搁置。

了解一下！！谢谢