印度某公司EU GMP检查失败被搁置7张CEP证书（分享）

印度某公司EU GMP检查失败被搁置7张CEP证书

EUGDMP数据库增加新的不符合信息

受检公司：印度 POLYDRUG LABORATORIES PVT. LTD.

检查日期：2015-3-18

官方：斯洛文尼亚

不符合事项：

共发现17个缺陷，其中有5个为主要缺陷，包括以下方面

1.      故意不把客户投诉记录在正式登记本里

2.      质量文件存放在非受控区域，该区域有QC、QA、维保和生产人员

3.      纸质文件管理有缺陷

4.      计算机化系统管理有缺陷

5.      原料药送外磨微粉但没有说明交叉污染的风险

上述这些主要缺陷合起来代表一个关键缺陷，导致对患者的潜在风险。

要采取的措施：

上市许可持有人要提交变更更换原料药供应商

EDQM要搁置或吊销CEP，所有原料药的CEP均被吊销：

CEP2009-112(三氯叔丁醇半水合物)

CEP2009-152(酒石酸美托洛尔)

CEP2009-170(琥珀酸美托洛尔)

CEP2010-147（富马酸铁）

CEP2010-247(呋康唑)

CEP2011-304(酒石酸美托洛尔)

CEP2011-312(琥珀酸美托洛尔)

The manufacturer : POLYDRUG LABORATORIES PVT. LTD.

Site address :

Plot No. 37, Anand Nagar, M.I.D.C., Ambernath (East), Maharashtra, IN - 421 506, India

Nature of non-compliance : Overall, 17 deficiencies were found, of which 5 Major consisting in: - Customer complaints deliberately unregistered in the official logbook - Storage of quality documents in an uncontrolled location, involving staff from QC, QA, maintenance and production - Deficient management of paper documents - Deficient management of the computerised system - Failure to address risks of cross contamination for APIs sent out to micronisation subcontractor. The combination of these major deficiencies represents a critical deficiency leading to a potential risk for the patient.

Action taken/proposed by the NCA :

Requested Variation of the marketing authorisation(s)
change of API supplier

Suspension or voiding of CEP (action to be taken by EDQM)
All CEPs have been suspended: CEP 2009-112 (Chlorobutanol hemihydrate), CEP 2009-152 (Metoprolol tartarate), CEP 2009-170 (Metoprolol Succinate), CEP 2010-147 (Ferrous fumarate), CEP 2010-247 (Fluconazole), CEP 2011-304 (Metoprolol tartarate), CEP 2011-312 (Metoprolol Succinate)

1/3/4问题好常见

国际注册注意事项

了解一下！！！！