中国FDA正在进行更多的国际检查

毒手药王

Chinese FDA is performing more international Inspections
中国FDA正在进行更多的国际检查
中国食品药品监督管理局发布了“2016年度药物检查年度报告”。本报告主要列出了CFDA在中国进行的检查总结。但在报告第五部分中，概述了国际检查活动：

去年在海外巡视的CFDA总数为19个国家，共检查49次。过去几年不断增长的数字：



这些检查大部分（33）在欧洲执行。六人在北美进行。报告中称，越南，印度等国家称为“具有较高地域质量风险的国家”。但是，只有一家印度公司被检查。

检查中涵盖了40种不同的产品（“化学品”），包括“注射剂，固体制剂，植入物和鼻喷雾剂”。

大多数观察是在质量控制和质量保证（22个有6个主要缺陷），材料系统和变更管理。严重缺陷主要表现为“生产过程和数据完整性一致性问题”。地方检查的缺陷主要体现在质量控制和质量保证和文件管理方面。

资料来源：中国药典2010年度药物检查年度报告

The China Food and Drug Administration (CFDA) has published its "Annual Report of Drug Inspection 2016". This report mainly lists summarised results of inspections performed by CFDA in China. But in Part V of the report, an overview is given on international inspection activities:

The total number of CFDA overseas inspections performed last year was 49 inspections in 19 countries. A number which has been constantly growing over the last years:

Most of these inspections (33) were performed in Europe. Six were performed in North America. Countries like Vietnam and India are called "countries with high regional quality risks" in the report. However, only one Indian company was inspected.

Overall, 40 different products ("chemicals") were covered in the inspections, including "injections, solid preparations, implants and nasal sprays".

Most observations were made in Quality Control and Quality Assurance (22 with 6 major deficiencies), Material System and Change Management. Serious deficiencies were mainly noted as "problems in the consistency of production process and data integrity". Deficiencies in local inspections were mainly observed in the areas of Quality Control and Quality Assurance and Documentation Management.

Source: CFDA Annual Report of Drug Inspection 2016

一片红云

一直在努力cfda

xqliu

就应该这样，有实践才有进步。

zysx01234

出去多走走，不掉队。

syhorchid

谢谢分享