翻译：
Julia
来源：
Julia法规翻译
Due to the Freedom of Information Act (FOI), the FDAmakes their inspection results available to the public. More rarely, however,the public gets informed about inspection results of EU supervisory authorities.The U.K. Medicines & Healthcare Products Regulatory Agency (MHRA) is apositive exception from this rule. Now, the
2016 GMP inspection deficiency datatrend
has been published by MHRA's GMDP Inspectorate.
由于自由信息法案（FOI），FDA会将其检查结果向公众发布。但是，EU监管当局向公众通报其检查结果的情况相对更少。英国药监（MHRA）则是一个正面的例外。现在，MHRA的GMDP检查团刚刚公布了其2016年GMP检查缺陷数据趋势。
According to MHRA they have "improved the way ofgathering the inspection deficiency data". The new data trending can nowallow stakeholders to identify:
根据MHRA的信息，他们已经“改进了收集检查缺陷数据的方式”。新的数据趋势现在可以让干系人找到：
-
The severity and frequency by the EU GMP references
-
依据EU GMP所判定的缺陷严重性和频次
-
The overall number of deficiencies by categories: Critical, Major, Other
-
按关键、重大和其它分类的缺陷的总计数量
-
The high impact vs. high frequency issues
-
重大影响
VS
高频次问题
In 2016, the MHRA has inspected 242 UK manufacturersand performed 82 inspections overseas. In the top-ten list of"critical" and "major" deviations found in all inspectedareas, findings regarding the quality system rank first. And there is a newnumber two: "Sterility Assurance", which wasn't even in the top tenin 2015 (see illustration 1). This is similar to recent FDA findings andthe same number one as in the previous year.
2016年，MHRA共检查了242个英国生产商，实施了82次海外检查。在所有受检领域中发现的“关键”和“重大”缺陷前10清单中，关于质量体系的缺陷排位第一。位居第二的是一个新项目“无菌保证”，在2015年这甚至都没有排在前十位中（参见图1）。这类似于FDA最近的发现，数据则与去年数量相同。
|
R
a
nki
n
g
排名
|
Gro
u
ps
类别
|
C
r
iti
ca
l
关键
|
Major
重大
|
Othe
r
s
其它
|
|
1
|
Qu
a
l
i
tyS
y
stem
质量体系
|
38
|
449
|
772
|
|
2
|
Steri
l
ityAss
u
ra
n
ce
无菌保证
|
34
|
190
|
162
|
|
3
|
Pro
d
ucti
o
n
生产
|
20
|
191
|
543
|
|
4
|
C
o
mp
l
a
i
ntsa
n
d R
e
ca
l
l
投诉和召回
|
11
|
80
|
1
10
|
|
5
|
Qu
a
l
i
ficati
o
n/
V
a
l
i
d
ati
o
n
确认
/
验证
|
10
|
123
|
232
|
|
6
|
Pr
e
m
i
s
e
s&E
qu
i
p
m
en
t
设施
&
设备
|
9
|
1
13
|
464
|
|
7
|
C
o
m
pu
ter
i
s
e
dS
y
ste
m
s
计算机化系统
|
9
|
44
|
120
|
|
8
|
P
e
rs
onne
l
人员
|
8
|
42
|
150
|
|
9
|
