印度工厂EU GMP检查发现58条缺陷 - 药群论坛

来源：http://zhuyujiao1972.blog.163.com/blog/static/9869472720141125111148817/

印度工厂EU GMP检查发现58条缺陷

信息来源：http://eudragmdp.ema.europa.eu/inspections/gmpc/searchGMPNonCompliance.do?ctrl=searchGMPNCResultControlList&action=Drilldown&param=26624

检查单位：法国药监French National Agency for Medicines and Health Products Safety

受检公司：MEDREICH LIMITED – UNIT V

受检地址：Plot n°45 A & B, Anrich Industriel Estate, Bollaram, Medak District, Andra Pradesh, 502325, India

检查日期：2014-05-16

不符合事项：检查期间共发现58项缺陷。本次检查为2013年1月28日至2月1日检查的跟踪检查。1个缺陷是关于数据造假，被列为“关键”。29个缺陷被定为“重大”，其中，

5个是关于质量管理水平太低（偏差管理系统不充分，没有全部的记录，没有分类，没有彻底的调查）；

3个是关于人员（对临时员工特别是质量关键操作如目视检查岗位的员工，没有正式的原则）；

5个是关于设备维保（除热源的）隧道和灌装用RABS、无菌起始物料取样用LAF……）

4个是关于文件记录（文件记录管理和数据完整性情况无法证明所记录的行动是真的；

9个是关于生产（无菌和非无菌产品），包括交叉污染的风险，目视检查过程操作很差、中控检查操作很差（瓶重、片重和硬胶囊）、破瓶处理很差。

备注：根据公司的申明，自从上次NCR签发后，没有成品批次在EU销售，因此不需要对成品进行召回。

French National Agency for Medicines and Health Products Safety

Report No : NCR/HPF/FR/1/2013 update

STATEMENT OF NON-COMPLIANCE WITH GMP

Exchange of information between National Competent Authorities (NCAs) of the EEA following the discovery of serious GMP non-compliance at a manufacturer (1)

Part 1

Issued following an inspection in accordance with :
Art. 111(7) of Directive 2001/83/EC as amended

The competent authority of France confirms the following:

The manufacturer : MEDREICH LIMITED – UNIT V

Site address :

Plot n°45 A & B, Anrich Industriel Estate, Bollaram, Medak District, Andra Pradesh, 502325, India

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2014-05-16 , it is considered that it does not comply with the Good Manufacturing Practice requirements referred to in

· The principles and guidelines of Good Manufacturing Practice laid down in Directive 2003/94/EC

__________________________________________________________________________________________________________________________

(1) The statement of non-compliance referred to in paragraph 111(7) of Directive 2001/83/EC and 80(7) of Directive 2001/82/EC, as amended, shall also be required for imports coming from third countries into a Member State.

Part 2

Human Medicinal Products

1 NON-COMPLIANT MANUFACTURING OPERATIONS

1.1 Sterile products

1.1.1 Aseptically prepared (processing operations for the following dosage forms)
         1.1.1.5 Solids and implants
                  Special Requirements:
                  1 B-lactam Antibiotics

1.2 Non-sterile products

1.2.1 Non-sterile products (processing operations for the following dosage forms)
         1.2.1.1 Capsules, hard shell
                  Special Requirements:
                  1 B-lactam Antibiotics
         1.2.1.13 Tablets
                  Special Requirements:
                  1 B-lactam Antibiotics

1.5 Packaging

1.5.1 Primary Packing
         1.5.1.1 Capsules, hard shell
                  Special Requirements:
                  1 B-lactam Antibiotics
         1.5.1.13 Tablets
                  Special Requirements:
                  1 B-lactam Antibiotics
1.5.2 Secondary packing

1.6 Quality control testing

1.6.1 Microbiological: sterility
1.6.2 Microbiological: non-sterility
1.6.3 Chemical/Physical

Part 3

Nature of non-compliance : 58 deficiencies have been raised during the inspection which was a follow-up of the inspection conducted from 28 January 2013 to 1 February 2013 (see NCR/HPF/FR/1/2013). 1 deficiency related to data falsification has been classified as "critical" . 29 deficiencies have been classified as "major". Among them, - 5 were related to poor level of quality management (inadequate deviations management system with no exhaustive record, no classification and no thorough investigation), - 3 were related to personnel (no formal policy on temporary workers specially for quality critical activities such as visual inspection), - 5 were related to the maintenance of equipment (depyrogenisation tunnel and RABS used for the filling operation, LAF used for the sampling of sterile starting materials ...), - 4 were related to documentation (documentation management and data integrity with difficulty to demonstrate that the actions recorded were genuine), - 9 were related to production (sterile and non-sterile products) including risk of cross contamination, poor visual inspection process handling, poor in-process control handling (weight of vials, weight of tablets and hard capsules), poor handling of broken vials issues.

Action taken/proposed by the NCA :

Prohibition of supply
The statement of non-compliance previously issued is maintained and the site should not be named on any marketing authorisations whilst this statement remains in place.

Additional comments : According to the company's statement, no batch of finished products has been distributed in the EU since the issuance of the previous NCR. This is the reason why no recall of finished products has been proposed

Teleconference Date :

Teleconference Time (CET) :

Dial in no. :

*2014-12-03*	Name and signature of the authorised person of the Competent Authority of France
	*Confidential* *French National Agency for Medicines and Health Products Safety* Tel : *Confidential* Fax : *Confidential*