翻译：JULIA 来源： Julia法规翻译
26.07.2017
The API warning letters of the last 21 months -facts and trends
过去
21
个月
API
警告信
----
事实与趋势分析
The number of warning letters addressed to API (ActivePharmaceutical Ingredient) manufacturers has increased considerably over thepast three years. 22 were issued in 2016; that is more than twice as much as inthe year before, when 10 manufacturers of active substances received theunpopular FDA letter.
在过去
3
年中，对原料药生产商签发的警告信数量大幅增加。在
2016
年签发了
22
封，这是前一年度数量的
2
倍还要多，而其中有
10
家原料药生产商收到此令人沮丧的
FDA
信函。
While the warning letters for pharmaceuticalmanufacturers are based on chapters of the "
Code of Federal Regulations, 21 CFR, Part211
", the citations in APIwarning letters refer to regulations in the chapters of guideline ICH Q7. Onthe contrary to the 21 CFR 211 chapters in pharmaceutical warning letters,those are not specified explicitly; however, the wording of main deficiencies(usually in bold print) in API warning letters literally reflects thecorresponding passages of
guideline ICH Q7
most of the time, so that a clear allocation ispossible in most cases. This also facilitates a simple statistical assessmentin regards to frequency distribution of deficiencies and the trends over aspecific period of time.
给药品生产商的警告信是基于联邦法典
21CFR
第
211
部分的，在
API
警告信中的引用则是来自
ICH Q7
指南。与
21CFR211
章节相反，在药品警告信中，这些写的并不是很清楚，但原料药警告信中主要缺陷的用词（通常是黑体显示）大多数时候反映的就是
ICH Q7
指南的对应段落。因此，在大多数案例中可以清楚锁定对应条款。这也有助于对频繁出现缺陷进行频次分布统计评估，并对指定时间段内的趋势进行分析。
Hereafter, some facts about the warning letters issuedto API manufacturers during the period of fiscal year 2016 (Oct. 15-Sept. 16)and the nine months of fiscal year 2017 (Oct. 16-Jun. 17) are listed.
下面列出了
2016
财年（
10
月
15
日至
9
月
16
日）以及
2017
财年
9
个月（
10
月
16
日至
7
月
17
日）签发给原料药生产商的警告信的一些情况。
Inspected Sites
受检地区
The share of production sites located in India orChina which received a warning letter is high in both considered periods.
印度和中国生产场所拿到的警告信在所统计时间段时占了很高比例。
|
地区
|
Land
|
Number of WLs in FY 2016
2016
财年数量
|
Number of WLs in FY 2017 (9 months)
2017
财年（
9
个月）数量
|
|
中国
|
China
|
10
|
9
|
|
印度
|
India
|
6
|
8
|
|
美国
|
USA
|
2
|
1
|
|
英国
|
United Kingdom
|
1
|
1
|
|
加拿大
|
Canada
|
1
|
0
|
|
意大利
|
Italy
|
1
|
0
|
|
德国
|
Germany
|
1
|
0
|
|
西班牙
|
Spain
|
0
|
1
|
|
日本
|
Japan
|
0
|
1
|
The numbers for the previous fiscal years are similar; this is a stable trendwhich will probably continue in the future.
之前财年的数字也是类似的，未来此趋势可能也会保持稳定。
It's interesting to take a look at the findingsdescribed in the warning letters of both periods.
看一下在两个时间段内的警告信中所述缺陷也是很意思的。
Frequencydistribution of quotes
所引用的缺陷条款分布频次
