意大利某药厂EU GMP检查失败

julia朱玉姣

检查方：意大利药监

被检查方: IASON ITALIA SRL

地址: Via GASTONE MARESCA, 38/38A, ROMA, 00138, Italy 意大利

检查日期：2015-10-8

产品：无菌人药

Nature of non-compliance : 不符合项

During the inspection 19 deficiencies were identified, 3 of them were rated as critical deficiencies and 11 as major deficiencies. The main deficiencies were related to the Quality Management and the Quality Assurance Systems also in terms of sterility assurance and risk of contamination/defects of the final product.

在检查期间发现19项缺陷，其中3个是关键缺陷，11个是主要缺陷。缺陷中主要内容是关于质量管理和质量保证体系，以及无菌保证和产品污染/缺陷风险。

One critical deficiency was related to failure to fully investigate and document out-of-specification results for microbiological environmental monitoring in class A isolator and class B/C surrounding areas, in manufacture of radiopharmaceuticals aseptically prepared.

一个关键缺陷是关于辐射药品生产中无菌处理时A级隔离器和B/C级背景区微生物环境监测OOS结果没有全面调查和记录。

The company didn’t carry out an appropriate and full-scale investigation to determine what caused the OOSs. An appropriate level of corrective action analysis was not applied during the investigation and the true root cause(s) were not determined. Failure to address the root cause due to ineffective CAPA revealed a lack of the quality assurance framework system.

公司没有进行适当全面的调查来确定是什么导致了这些OOS。在调查期间，没有实施适当水平的纠正措施分析，没有确定真正的根本原因。由于无效的CAPA导致未能说明根本原因，显示出公司缺乏质量保证框架体系。

Another critical deficiency was reported with regards to production processes which were considered not satisfactory controlled: it was found that for the manufacture of some batches of the radiopharmaceutical Pcolina (Iasocholine) a non suitable reagent was used (expired dibromomethane).

另一个关键缺陷是关于生产工艺控制不够充分：发现有些辐射药品PCOLINA（LASOCHOLINE）批次的生产使用了不恰当的试剂（过效期的二溴甲烷）。

Moreover, for some batches of released RPs master batch documents were incomplete. No adequate review by QA or QP. Furthermore, preparation of the starting material set for radiopharmaceuticals was performed in condition not appropriate to guarantee an adequate level of chemical and microbiological containment.

另外，许多批次放行RP主批文件不完整。QA或QP没有进行充分的审核。另外，辐射药品起始物料的制备条件不适当，不能保证防止化学和微生物污染。

The inspection’s team has rated also as critical the observation related to the number of personnel in force to the manufacturing site, which were considered not appropriate to conduct all the activities in accordance with the GMP and to maintain the quality management system and its effectiveness.

检查团还将生产场所的人员数量相关的缺陷作为是关键缺陷，这些人员数量被认为不适当来按GMP实施所有活动，以及维护质量管理体系和其有效性。

The remaining major deficiencies were related to specific aspects of the Quality Assurance System with regards to PQR assessment, revalidation and recalibration of critical equipment, data integrity in the context of HPLC management, storage of materials and documentation system.

余下的主要缺陷是关于质量保证体系的特定方面，关于PQR评估、关键设备再验证和再校正，HPLC管理数据完整性、物料存贮和文件体系。

孙艳红

这种情况怎么能保证无菌药品质量？为意大利药监点赞

julia朱玉姣

检查方：意大利药监

被检查方: IASON ITALIA SRL

地址: Via GASTONE MARESCA, 38/38A, ROMA, 00138, Italy 意大利

检查日期：2015-10-8

产品：无菌人药

Nature of non-compliance : 不符合项

During the inspection 19 deficiencies were identified, 3 of them were rated as critical deficiencies and 11 as major deficiencies. The main deficiencies were related to the Quality Management and the Quality Assurance Systems also in terms of sterility assurance and risk of contamination/defects of the final product.

在检查期间发现19项缺陷，其中3个是关键缺陷，11个是主要缺陷。缺陷中主要内容是关于质量管理和质量保证体系，以及无菌保证和产品污染/缺陷风险。

One critical deficiency was related to failure to fully investigate and document out-of-specification results for microbiological environmental monitoring in class A isolator and class B/C surrounding areas, in manufacture of radiopharmaceuticals aseptically prepared.

一个关键缺陷是关于辐射药品生产中无菌处理时A级隔离器和B/C级背景区微生物环境监测OOS结果没有全面调查和记录。

The company didn’t carry out an appropriate and full-scale investigation to determine what caused the OOSs. An appropriate level of corrective action analysis was not applied during the investigation and the true root cause(s) were not determined. Failure to address the root cause due to ineffective CAPA revealed a lack of the quality assurance framework system.

公司没有进行适当全面的调查来确定是什么导致了这些OOS。在调查期间，没有实施适当水平的纠正措施分析，没有确定真正的根本原因。由于无效的CAPA导致未能说明根本原因，显示出公司缺乏质量保证框架体系。

Another critical deficiency was reported with regards to production processes which were considered not satisfactory controlled: it was found that for the manufacture of some batches of the radiopharmaceutical Pcolina (Iasocholine) a non suitable reagent was used (expired dibromomethane).

另一个关键缺陷是关于生产工艺控制不够充分：发现有些辐射药品PCOLINA（LASOCHOLINE）批次的生产使用了不恰当的试剂（过效期的二溴甲烷）。

Moreover, for some batches of released RPs master batch documents were incomplete. No adequate review by QA or QP. Furthermore, preparation of the starting material set for radiopharmaceuticals was performed in condition not appropriate to guarantee an adequate level of chemical and microbiological containment.

另外，许多批次放行RP主批文件不完整。QA或QP没有进行充分的审核。另外，辐射药品起始物料的制备条件不适当，不能保证防止化学和微生物污染。

The inspection’s team has rated also as critical the observation related to the number of personnel in force to the manufacturing site, which were considered not appropriate to conduct all the activities in accordance with the GMP and to maintain the quality management system and its effectiveness.

检查团还将生产场所的人员数量相关的缺陷作为是关键缺陷，这些人员数量被认为不适当来按GMP实施所有活动，以及维护质量管理体系和其有效性。

The remaining major deficiencies were related to specific aspects of the Quality Assurance System with regards to PQR assessment, revalidation and recalibration of critical equipment, data integrity in the context of HPLC management, storage of materials and documentation system.

余下的主要缺陷是关于质量保证体系的特定方面，关于PQR评估、关键设备再验证和再校正，HPLC管理数据完整性、物料存贮和文件体系。

一沙一叶

也不怎么样啊

工作QQ

19项，3严重，11主要，罗马的这家药厂有点虚。楼主，海南赞邦听说2007年就过了欧盟GMP,怎么查不到，母公司是zambon.

syhorchid

了解一下

清风化雨

值得借鉴!!

ach成

不是所有国家的药企都是严格按要求生产的，或多或少总会有一些问题存在，但主要还是怎么解决这些问题，才能让药企能够做的更好，走的更远

十二月的雪

走自己的路，让药监查去吧！！！

jennymonkey

看来，咱们国家的大部分也都还行啊！

道路漫长黑暗

看来只是做了永远不够，还是要求做好啊。

媛媛秀水

新人，学习学习

秋叶飘飘

值得借鉴。