印度2工厂EU GMP检查失败

julia朱玉姣

印度2工厂EU GMP检查失败

来源：http://eudragmdp.ema.europa.eu/inspections/gmpc/searchGMPNonCompliance.do

工厂名称：Anuh Pharma LTD

检查方：法国药监

受检地址：E-17/3 & E 17/4 M.I.D.C., Tarapur, Thane District, Boisar,Maharashtra, 401 506, India

检查时间：2016-2-12

产品：非无菌原料药

不符合情况：总共发现24个缺陷，其中一个关键缺陷，2个主要缺陷

Nature of non-compliance : Overall, 24 deficiencies were observed during the inspection, 1Critical and 2 Major deficiencies:

* * * [Critical 1] No transfer ofinformation to the user of the active substance as regards to the originalmanufacturers of the active substances only micronized at the site (i.e.manufacturer name, original batch number and COA) and exported to Europe orthat may be sold to distributors exporting to Europe. The following activesubstances were micronized from other sources (as communicated by the company -may not be exhaustive): Azithromycin, Chloramphenicol, ChloramphenicolPalmitate, Ciprofloxacin HCl, Clarithromycin, Piperaquine phosphate,Roxithromycin and Sulfadoxine. Moreover, a non EU-GMP compliant source forAzithromycin (NCF/010/RO, Hebei Dongfeng Pharmaceutical Co., Ltd, China) wasmicronized and directly exported to Europe under the manufacturer name AnuhPharma.

关键缺陷：没有将自己工厂仅做了微粉工艺的活性物质原始生产商的信息转告给用户（即生产商名称、原始批号和COA），出口至欧洲，或者可能通过分销商出口至欧洲。以下活性物质是来自另一个来源，进行了微粉（与公司沟通所得----可能不是全部清单）：阿奇霉素、氯霉素、棕榈酸氯霉素、盐酸环丙沙星、克拉霉素、磷酸哌喹、罗红霉素和磺胺多辛。另外，有一个不符合EU GMP的阿奇霉素来源（NCF/010/RO，河北东风制药，中国）的产品被微粉然后直接以ANUH PHARMA的生产商名出口至欧洲。

* * * [Major 1] Deficiencies indocumentation management. Several documents were found within a pile of rubbleon the other side of a wall. These included an original batch repacking recordwhich should have been placed under retention and a large number of purchaseorders dated from 2013 for active substances, notably Azithromycin, Chloramphenicol,Chloramphenicol Palmitate, Roxithromycin and Ciprofloxacin HCl.

主要缺陷1：文件记录管理。在墙的另一边一堆碎石中发现几个文件。其中包括一份原始包装批记录，它被替换了，然后保存，有一堆采购订单，日期从2013年开始，采购的产品是活性物质，即阿奇霉素、氯霉素、氯霉素棕榈酸、罗红霉素和盐酸环丙沙星。

* * * [Major 2] Deficiencies in processvalidation. No validation data was available for the blending of micronizedbatches. No cleaning validation was available for one air jet mill used formicronization. No supporting data for the reduced testing of the recoveredEthyl Acetate solvent was available.

主要缺陷2：工艺验证缺陷。微粉后的批次的混合没有验证数据。一个用于微粉工艺的气流粉碎机没有清洁验证。没有数据支持回收乙酸乙酯溶剂的减少测试。

被搁置CEP：

CEP 2007-235 (Erythromycin Ethylsuccinate),

CEP 2005-059 (Pyrazinamide),

CEP 2005-205 (Erythromycin).

工厂名称：RUSAN PHARMA LTD

检查方：英国药监

受检地址：Plot 59 to 65, Sector II Kandla Special EconomicZone, Kutch, Gandhidham, Gujarat, 370230, India

检查时间：2016-1-22

产品：非无菌人用药品：胶囊，硬壳      半固体，片剂，其它：颗粒和干糖浆。报告里有一长列清单。

不符合情况：

Nature of non-compliance : The Pharmaceutical Quality system was not operating in an adequatemanner to ensure that patient safety was adequately protected and there was notadequate evidence that the root causes of critical data integrity issues raisedat the last inspection had been addressed. 1. There was a widespread failure ofthe Quality Management System including core systems. 2. The control ofelectronic data and laboratory systems was not adequately robust and could notassure data traceability or security. 3. Systems to control contamination weredeficient and could not assure adequate assessment of the risk of crosscontamination. 4. Critical controls within the packaging areas were notadequately robust or controlled. 5. Training was deficient in that there was norobust process for managing training and untrained analysts were performinganalyses.

PQS运行不充分，不能确保患者安全受到充分保护，没有足够的证据证明上次检查中提出的关键数据完整性问题的根本原因被解决。

1.      QMS包括核心体系大范围失败。

2.      电子数据和化验室控制不够强，不能确保数据可追溯性和安全性。

3.      控制污染的体系不充分，不能确保交叉污染风险经过充分评估。

4.      包装区域关键控制不够强，或者没有控制。

5.      培训有缺陷，没有足够完善的流程管理培训，未经培训的化验室在进行分析操作。

备注：2012年11月已签发过不符合报告。自那时起并无产品出口至欧洲。

zysx01234

呵呵，印度阿三，只能当下流三，活该。

zysx01234

貌似这个楼主之前发过了吧

jacob3263313

主要缺陷1：文件记录管理。在墙的另一边一堆碎石中发现几个文件。其中包括一份原始包装批记录，它被替换了，然后保存，有一堆采购订单，日期从2013年开始，采购的产品是活性物质，即阿奇霉素、氯霉素、氯霉素棕榈酸、罗红霉素和盐酸环丙沙星。
这个厉害了，检察官还附带刨祖坟吗

祁莉萍_P4B80

一堆碎石中发现。。。。。咋不刨个坑埋起

syhorchid

印度两药厂又中枪