EMA给印度无菌药品生产商的不符合报告

26.07.2017

EMA non-compliance report on Indian manufacturer of sterile medicinal products

EMA给印度无菌药品生产商的不符合报告

Non-compliance reports are published in the EudraGMDP database of the European Medicines Angency (EMA) by European supervisory authorities. They refer to inspecti** inside as well as outside of the European Union. The non-compliance reports are independently submitted into the database by National Competent Authorities via a standardised form. For the company concerned, a non-compliance report has severe c**equences until the violati** are rectified. Amongst other things, a suspension of the marketing authorisation as well as recalls of the products in question could be mandated.

欧洲监管机构签发的不符合报告会发布在EMA的EUGMDP数据库中。其中列出了对欧盟内外场所实施的检查。不符合报告是由各国家药监机构通过标准格式上传至数据库的。对于受检公司来说，不符合报告会有严重的后果，直至违规行为被纠正。此外，受影响的药品上市许可可能会被搁置，产品可能会被召回。

On July, 5th 2017, the EMA published a non-compliance report on the Indian company Biocon Limited in Bangalore, which was inspected by the French supervisory agency "French National Agency for Medicines and Health Products Safety". During a pre-approval inspection, they observed 35 deviati** in 3 Biosimilar-products, 11 of which were major deviati** concerning the following topics:

2017年7月5日，EMA发布了一份印度公司BIOCON的不符合报告。该公司是由法规药监进行的药品批准前检查，检查中发现35项生物类似物缺陷，其中11项为主要缺陷，相关缺陷领域如下：

• Environmental monitoring
• 环境监测
• Employee training
• 员工培训
• Handling of OOS results
• OOS结果处理
• Cleaning validation
• 清洁验证
• Process validation
• 工艺验证
• Supplier qualification
• 供应商确认
• Media Fill tests
• 培养基灌装测试
• Cross con**ination risks
• 交叉污染风险
• Batch records
• 批记录
• Handling of differential pressure alarms in classified areas
• 不同洁净级别间的压差报警处理
• Access management in SAP for batch release
• 批放行用SAP管理权限问题
  

Alas, unlike in FDA warning letters, deficiencies aren't more closely specified. As a c**equence of this inspection, the 3 products will get no marketing authorisation until the deficiencies are corrected.

天啊，跟FDA警告信不一样，这些缺陷都没有进一步详细说明的。由于此次检测，缺陷纠正之前还不能获得3个产品的上市许可。

Source: EudraGMDP database of the EMA

来源：Julia