EMA国际原料药联合检查项目报告（2011-2016）

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EMA国际原料药联合检查项目报告（2011-2016）
Report on the International Active Pharmaceutical IngredientInspection Programme 2011 – 2016

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1、944 unique sites* were submitted by 9 reporting authorities (EMA, AIFA, ANSM, DKMA, MHRA,  EDQM, FDA, TGA, WHO).
在这些国家组织外的，并在这些国家组织注册可检查的API生产场地共计944个；
2、458 unique sites (49% of all sites submitted) were of common interest.These 458 sites were located in 18 countries: primarily India with 226 sites, China with  165 sites, and the remaining 67 located in 16 countries around the world
其中有458个可检查API场地涉及到在这些国家组织中的两方或多方注册；
其中印度226家，中国165家，其他16个国家67家；
其他486个生产场地仅在这些国家组织的一方进行注册；
3、Of the 458 sites of common interest, there were 1333 total unique inspections by the participating authorities over the 6-year period, resulting in an average 2.9 inspections per site in the review period.
Overall, 28% of the total number of sites inspected during this period had at least one non-compliant inspection, and were inspected on average 3.6 times. This is compared to the 72% of
sites with a compliant history  that were inspected 2.7 times per site in the study time frame.
这458个涉及到多方注册的API生产场地，6年中平均接受的各方检查是2.9次（即平均约每2年一次），其中涉及到出现non-compliance的生产场地(大约28%）6年的平均检查是3.6次 ，而拥有合规记录的生产场地（大约72%）6年平均检查次数是2.7次；
4、There were 47 joint inspections conducted at 43 sites in the six-year period of review. Four  sites hosted joint inspections twice in the time period.
6年中有43个生产场地接受了47次联合检查，其中有4个生产场地6年接受了2次联合检查（不知道是哪四个生产场地？？）  
5、Increase visibility of the programme to industry
该项目后期将对企业进一步增加可预见性
6、总的来说
a、后期联合检查可能会更加依靠各方的检查结果进行判断，减少不必要的重复检查，从而减少了企业准备检查的负担（当然至少是维持在当下的“2年一检”的程度）。当然也相应的增加了每次检查的重要性；
b、检查进一步扩展到非共同关注的生产场地（即仅在其中一方注册的API生产场地），以增加相应的API生产场地检查的覆盖面（哪些侥幸很久没有检查的API生产场地，可能会相应的增加被检查的频率）；

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