美国2家药厂被EU GMP检查结果不符合

julia朱玉姣

生产商：PHARMACEUTICSINTERNATIONAL INC

受检地址：103 BEAVER COURT,COCKEYSVILLE, 21030, United States

检查日期：2016-02-26

签发日期/上网日期：2016-06-15

检查方：英国

产品：无菌冻干、小容量注射液

Nature ofnon-compliance : 不符合情况

The inspectionidentified two critical deficiencies:

检查发现2个关键缺陷：

(1) failure oforganisational and technical measures to minimise the risk cross-contaminationbetween hazardous and non-hazardous products manufactured in the samemanufacturing facilities using shared equipment.

未能采用组织和技术方式来将同一生产场所共用设备所生的有害产品与无害产品之间的交叉污染风险减至最低。

(2) Failure ofthe quality unit to ensure the effective operation of the quality system. Thisincluded a gross failure of change management, permitting the use of anunqualified HPLC system and unacceptable approach to production equipmentqualification. Quality investigations also lacked implementation of qualityrisk management principles.

质量部门未能保证质量体系有效运行。包括变更管理大量失败情况，允许使用未经确认的HPLC系统，采用不能接受的方法进行生产设备确认。质量调查没有应用质量风险管理原则。

Three majordeficiencies were also identified:

发现3个主要缺陷：

(1)organisational data governance failures, particularly relating to generationand checking of analytical data obtained from electronic systems, andinadequate investigation into previous data integrity failures.

数据管理组织失效，尤其是从电子系统获取的分析数据的生成和检查方面，对之前的数据完整性失败的调查不充分。

(2)deficiencies in sterilisation and depyrogenation processes, and

灭菌和除热源工艺有缺陷。

(3)insufficient control of aseptic operations to provide the required level ofsterility assurance.

对提供无菌保证所需的无菌操作控制不充分。

Action taken/proposed by the NCA :

NCA所采取或提议采取的措施：

Recall of batches already released 召回已经放行的批次
Based on the identified GMP deficiencies, recall of product is recommended,where market alternatives and medical criticality permits.

基于发现的GMP缺陷，建议在市场可替代和医疗关键程度允许的情况下召回产品。

Prohibition of supply 禁止供应
No future batches of non-critical product to be supplied to the EU while thisstatement of non-compliance remains in force

不符合报告保持有效期间未来非关键产品不得销售到EU市场。

Suspension of clinical trials 临床试验搁置
The proposal to continue supply individual batches ofinvestigational medicinal product should be submitted as a substantialamendment, supported by a risk assessment and demonstrating a positive benefitrisk ratio for trial subjects. This should be authorised by the NationalCompetent Authority.

要将继续供应单批产品用于临床药品的提议提交作为重大增补，并使用风险评估作为支持，证明对受试对象利大于弊。这应该获得国家药监局的批准。

Additionalcomments :   National Competent Authoritiesshould evaluate the criticality of products being supplied by thismanufacturing site and enact measures to ensure continued supplies whereappropriate. Marketing authorisation holders are requested to contact therelevant National Authority to verify whether their products are consideredmedically critical to public health in their territory and therefore outsidethe scope of the non-compliance statement. The scope of this statement ofnon-compliance also applies to chemical / physical quality control testing (GMPin-process and stability analysis) at the adjacent site; 10950 Beaver Dam Road,Hunt Valley, MD 21031 USA.

额外建议：各国家药监局应评估由此生产场所供应的药品的关键程度，适当时，采取必要的措施来保证持续供应。上市许可持有人必须与相关的国家药监局联系，核对其产品是否被认为是其国家医疗关键药品，从而需要置于不符合声明范围以外。此不符合声明的范围适用于相邻工厂10950 Beaver Dam Road, Hunt Valley, MD 21031USA化学/物理质量检验（GMP中控和稳定性分析）。

生产商：PHARMACEUTICSINTERNATIONAL INC 受检地址：10819 GILROY ROAD, HUNTVALLEY, 21031, United States检查日期：2016-02-26签发日期/上网日期：2016-06-15检查方：英国产品：   1.2.1.1    Capsules, hard shell 硬胶囊
           1.2.1.2    Capsules, soft shell 软胶囊
           1.2.1.6    Liquids for internal use 内用液体
           1.2.1.13    Tablets 片剂
           1.2.1.17    Other: Vaginal tablets (pessaries) andgranules/powders(en) 其它：阴道片（阴道栓）和颗粒/粉料不符合情况：与上述相同Action taken/proposed by the NCA : NCA采取或建议采取的行动：Withdrawal, of current valid GMP certificate No. UK GMP 22917 Insp GMP22917/37149-0006
Withdrawal of UK GMP 22917 Insp GMP 22917/37149-0006吊销目前有效的GMP证书Recall of batches already released
Based on the identified GMP deficiencies, recall of product is recommended,where market alternatives and medical criticality permits.召回已经放行的批次Prohibition of supply
No future batches of non-critical product to be supplied to the EU while thisstatement of non-compliance remains in force禁止销售Suspension of clinical trials
The proposal to continue supply individual batches of investigational medicinalproduct should be submitted as a substantial amendment, supported by a riskassessment and demonstrating a positive benefit risk ratio for trial subjects.This should be authorised by the National Competent Authority.暂停临床试验

zdlxcb

谢谢分享，周末愉快！

阿炳1987

后背一凉，突然感觉到一股杀气，制药企业不好混咯...

北重楼

数据管理组织失效，尤其是从电子系统获取的分析数据的生成和检查方面，对之前的数据完整性失败的调查不充分。

syhorchid

外国的东西并非都是好的，这不，美国也有药厂被EU GMP检查结果不符合的嘛。

zysx01234

好，美国佬

zysx01234

好，美国佬

gyhjxw

美国佬也不行啊

日出沧海

非常好               

qiyl2008

thanks for sharing ,have a good weekend!!

兰卡威

到处都一样啊

kc1711422001

Thanks for sharing

wuhuaguo54321

质量部门未能保证质量体系有效运行。包括变更管理大量失败情况，允许使用未经确认的HPLC系统，采用不能接受的方法进行生产设备确认。质量调查没有应用质量风险管理原则。

这个有意思啊

zpzjm2010

谢谢楼主的分享。

天睦

天下乌鸦一般黑，其实是有道理的
药厂所面临的问题也是一样一样的