印度百康3个产品的不符合报告

Non-Compliance Report for manufacturing of three Products at Biocon, India印度百康3个产品的不符合报告

On 5 July a Non-Compliance Report (NCR) of the French National Agency for Medicines and Health Products Safety (ANSM) was published on the EudraGMDP site. Between 13 and 17 March 2017, the ANSM performed a pre-approval inspection at Biocon Limited in Bangalore, India, on behalf of the European Medicines Agency (EMA). During that inspection, it was c**idered that the manufacturing of three biosimilar products does not comply with the Good Manufacturing Practice requirements according to the principles and guidelines of Good Manufacturing Practice laid down in Directive 2003/94/EC.

7月5日，法国药监在欧盟GMDP数据库内发布了不符合报告（NCR）。在2017年3月13-17日，ANSM代表EMA对印度百康公司进行了批准前检查。在检查期间，ANSM认为3个类似物的生产不符合2003/94/EC里规定的GMP要求原则和指南。

The inspection showed noncompliant manufacturing operati** amongst others in aseptically prepared Lyophilisates and small volume liquids, in secondary packaging and in the microbiological, chemical and biological quality control testing. The report summarized the following issues for three products:

检查显示在冻干和小容量液制备、外包和微生物、化学和生物质量控制检测方面生产操作不合规。报告中总结了三个产品以下违规情况：

"Fulphila? (Pegfilgrastim), pre-filled syringe presentation: drug product manufacture (block B1) and quality control operati**; - Ogivri? (Trastuzumab), vial presentation (freeze-dried product): drug product manufacture (block B1) and quality control operati**; - Semglee? (Insulin glargine), cartridge presentation: secondary packaging (block B2) and drug product quality control. This NCR is limited to the drug product manufacturing activities related to these 3 products. This inspection raised 35 deficiencies, including 11 major deficiencies on the following topics: -Environmental monitoring -Training; -OOS results management ; -Cleaning validation ; -Process validation; -Vendors qualification; -Media fill test; -Cross-con**ination risks; -Batch manufacturing record; -Differential pressure alarms' management in classified areas; -Access management in SAP for batch certification"

Fulphila? (培非格司亭)，预灌装注射针：药品生产（B1生产区）和质量控制操作；Ogivri? (曲妥单抗)，西林瓶（冻干药品）：药品生产（B1生产区）和质量控制操作；Semglee? (甘精胰岛素)，药管：外包（B2生产区）和药品质量控制。此NCR限于与此3个产品有关的药品生产活动。此次检查发现35个缺陷，包括以下方面11个主要缺陷：环境监测、培训、OOS结果管理、清洁验证、工艺验证、供应商确认、培养基测试、交叉污染风险、批生产记录、洁净区压差报警管理、用于批认证的SAP权限管理。

According to the Non-Compliance Report, the Marketing Authorisation for these products is still under assessment, and as long as the NCR is in force, no batches of these products manufactured prior to the issuance of the report should be supplied to Europe.

根据不符合性报告，这些产品的上市许可仍在评估中，只要NCR仍有效，在报告签发之前生产的此三产品所有批次均不得销往欧洲。

For more details please see the statement of non-compliance with GMP.

更多细节，参见GMP不符合报告声明。

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