西班牙ALCOR欧盟检查失败

julia朱玉姣

公司名称：ALCOR, S.L.

受检地址：Poligono Industrial del Henares, Juan de Anstria 142,Guadalajara, 19004, Spain

检查日期：2016-6-15

检查方：西班牙

产品：非无菌内服制剂

不符合情况：

Nature ofnon-compliance : The objective and scope of theinspection conducted on 15 and 16 June 2016 was to verify compliance of thissite with EU Good Manufacturing Practices (hereafter EU GMP), with regard tothe manufacturing of liquids for internal use: syrup (Jarabe Dr. Manceau 60 y120 ml) , oral solution (Denticelso).

2016年6月15-16日实施的检查目标和范围是核查现场与EU GMP的符合性，检查对象是内服液体的生产：糖浆（JARABE DR. MANCEAU 60Y120ML），口服液（DENTICELSO）.

During theinspection conducted on 15 and 16 June it was found that the company does nothave suitable facilities, personnel and materials resources to ensure propercompliance with GMP. A total number of 29 deficiencies were identified. Eightof them were classified as major.

在检查期间，发现公司没有适当的设施、人员和物料来源，不能保证符合GMP要求。发现缺陷达29个，其中8个被列为主要缺陷。

The companyproposed a corrective action plan on 8 and 29 July 2016. After its evaluation,on 2 August 2016 the inspectorate concludes there are many outstanding issuesand that Alcor S.L. does not comply with EU GMP requirements. In general theproposed corrective actions were insufficient, diffuse and do not provide adescription about the extent of the measures, so to ensure the correction ofthe major deficiencies. In particular, those related to the lack of personnelremain unsolved, and the an accumulation of tasks and responsibilities in somepersonnel is a risk to quality. It does not ensure the proper conduct of the activitiesrequired for EU GMP compliance.

公司于2016年7月8-29日提出了纠正措施，在评估之后，在2016年8月2日检查团得出结论认为有许多突出的问题，ALCOR不符合EU GMP要求。总体来说，其所提交的整改措施是不充分的、分散的，没有提供措施的程度的描述，不能保证对主要缺陷的纠正。尤其是，那些与人员短缺相关的缺乏仍不能解决，一些人员工作和职责累积形成质量风险，不能保证适当实施符合EU GMP所需的活动。

Otheroutstanding issue is the lack of a quality control laboratory suitable forperforming chemical-physical testing and microbiological testing .

另一突出的问题是缺乏适于实施理化检查和微生物检测的QC化验室。

Moreover, someof the findings detected such as bad documentation practice, inadequatemanagement of raw material suppliers’ and services providers, poor product andmaterials identification and deficient periodic control of the critical aspectsof operations through qualification and validation processes in facilities, equipment,utilities and processes, indicate the existence of major deviations from EU GMPthat could lead to a product of dubious quality .

另外，有些缺陷，如不良的文件记录规范，原料供应商和服务提供商管理不充分，产品和原料鉴别不好，设施、设备和工艺整个确认和验证中关键操作方面的定期控制不足，同与严重偏离EU GMP，使得产品质量受疑。

zysx01234

尤其是，那些与人员短缺相关的缺乏仍不能解决，一些人员工作和职责累积形成质量风险，不能保证适当实施符合EU GMP所需的活动。——这是比较实在的搓中很多小企业的软肋，就是人很少，一个人当多个人用

kc1711422001

Thanks for sharing

adou

“在检查期间，发现公司没有适当的设施、人员和物料来源”，比较喜欢这样的检察官，这样我们就不需要一人身兼数职了。

syhorchid

西班牙药企也中枪

一沙一叶

不过如此而已，真不怎么样