一家欧洲无菌药品生产商的不符合报告

20160309 ECA新闻：一家欧洲无菌药品生产商的不符合报告  

   

原文网址：http://www.gmp-compliance.org/enews_05230_FDA-Guideline-on-Dissolution-Testing.html

GMP News
09/03/2016

Non-Compliance Reports for EuropeanManufacturers of Sterile Medicinal Products

一家欧洲无菌药品生产商的不符合报告

Non-Compliance reports are published bynational competent authorities in the EudraGMDP database of the EuropeanMedicines Agency (EMA). They relate to inspections both withinand outside the European Community (European Union). The Non-Compliance reportsare entered into the database by the national competent authoritiesindependently using a standardised form. Such a Non-Compliance report hasserious consequences for the company concerned until the deficiencies have beenrectified. A suspension of the marketing authorisation as well as productrecalls can be ordered.

EMA的EUGMDP数据库里由各国药监局负责发布不符合报告，其中包括欧盟境内外的检查。不符合报告由国家药监使用标准格式独立录入。这样的不符合报告在缺陷被纠正之前具有严重的后果。上市许可会被搁置，药品会被要求召回。

On 2nd February 2016, the Spanishcompetent authority published a Non-Compliance report for the Spanish companyFarma Mediterrania S.L. Beside deviations in the areas of secondary packing andQC, considerable deficiencies with regard to sterile manufacturing have beencriticised. One of them relates to sterility tests: their results have beenaccepted uncritically although no investigation had been performed to determinethe root cause of previous OOS sterility tests. Furthermore, the followingmajor deficiencies were found:

在2016年2月2日，西班牙药监局公布了一份关于西班牙FARMA公司的不符合报告。除了在外包装和QC发现的缺陷外，还发现了无菌生产中重大缺陷。其中一个在关于无菌测试的：其之前的无菌测试检测结果为OOS，没有进行调查来确定根本原因，就接受了该结果。另外，还发现以下主要缺陷：

·        Media Fills haven't been performed every six months andsamples used in the simulation haven't been incubated at the right temperature.

·        培养基灌装没有每6个月实施，模拟用样品培养温度不对。

·        The air treatment system hasn't been sufficiently qualifiedas it is only checked when it is "at rest" but not "inoperation".

·        空气处理系统验证不充分，因为只是检查了“静态”没有检查“动态”。

·        No test performed of growth promotion of culture mediaused in the sterility testing, in Media Fill and in microbiologicalenvironmental monitoring

·        无菌测试、培养基灌装和微生物环境中监测所用培养基没有做促生长试验。

On 19 January 2016, thePolish competent authority (GIF) released a Non-Compliance report for thePolish subsidiary Agila Specialities Polska Sp. z o.o. This Non-Compliancereport relates almost exclusively to "sterile topics" and lists 29major deficiencies - among them:

2016年1月19日，波兰药监发布了对AGILA一家波兰分支机构的不符合报告。此不符合报告几乎全是“无菌话题”，列出了29条主要缺陷，其中有：

·        Design and qualification of the HVAC, laminar air flowsystem and clean areas

·        HVAC、层流系统和洁净区设计和确认

·        Cleaning and maintenance of clean areas

·        洁净区的清洁和维护

·        Production and batch release didn't fulfil the GMPrequirements

·        生产和批放行不满足GMP要求

·        Change controls for significant modifications of thefilling lines. No re-qualification after the changes have been made.

·        灌装线的重大改造的变更控制。在变更后没有进行重新确认。

·        Pressure differential between clean areas B and C < 10Pa

·        洁净区B级和C级间的压差<10帕

·        Inexistent or insufficient maintenance in the cleanrooms

·        洁净间没有维护或维护不充分

·        The filtration process was not fully validated.

·        过滤工艺没有全面验证

·        Lack of A grade in a lyophilizer

·        冻干机不在A级区

Source: EudraGMDP Database of the EMA

来源：EMA的GMDP数据库

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