USP分析仪器确认中英文对照

2021年1月25日发(作者：tony是什么意思)

<1058> ANALYTICAL INSTRUMENT QUALIFICATION
分析仪器的确认

INTRODUCTION
介绍

A large variety of laboratory equipment, instruments, and
computerized analytical systems, ranging from simple nitrogen
evaporators to complex multiple-function technologies (see
Instrument Categories
), are used in the pharmaceutical industry
to acquire data to help ensure that products are suitable for their
intended use. An analyst
'
s objective is to consistently obtain
reliable and valid data suitable for the intended purpose.
Depending on the applications, users validate their procedures,
calibrate their instruments, and perform additional instrument
checks, such as system suitability tests and analysis of in-process
quality control check samples to help ensure that the acquired data
are reliable. With the increasing sophistication and automation of
analytical instruments, an increasing demand has been placed on
users to qualify their instruments.
极其多种多样的实验室设备、仪器、计算机分析系统，从简单的氮吹

仪到复杂的
多功能技术（见

仪器种类

），被应用于制药工业，以取得

数据来确保产品适
合其预定用途。

分析员的目标是持续地获得适合其

意图的可靠和有效的数据。
取决于具体的应用，使用者验证其方法、

校准其仪器，

并进行额外的仪器检
查，

例如系统适用性测试和中间质

量控制检查样品的分析，

以便帮助确保所获


得的数据是可靠的。

随着

分析仪器的复杂性和自动化程度不断增加，

使用者已
经感受到了不断

增加的确认其仪器的要求。

Unlike method validation and system suitability activities,
analytical instrument qualification (AIQ) currently has no specific
guidance or procedures. Competing opinions exist regarding
instrument qualification and validation procedures and the roles
and responsibilities of those who perform them. Consequently,
various approaches have been used for instrument qualification,
approaches that require varying amounts of resources and generate
widely differing amount of documentation. This chapter provides a
scientific approach
to
AIQ and considers AIQ as one of the major components required for
generating reliable and consistent data. Note that the amount of
rigor applied to the qualification process will depend on the
complexity and intended use of the instrumentation. This approach
emphasizes AIQ
'
s place in the overall process of obtaining the
reliable data from analytical instruments.
不同于验证和系统适用性工作，分析仪器的确认（

AIQ
）目前尚没有

具体的指导方针或程序。

关于仪器确认和验证程序，

以及这些程序的

执行者的
角色和职责，存在着相互冲突的多种观点。由此导致，多种

方法已经应用于仪器
确认，

而这些方法要求使用的资源数量各异并产

生数量差距很大的文档。此通


则为

AIQ
提供了科学的方法，并将

AIQ
视为产生可靠和一致的数据所必需的主
要组成部分之一。

注意，应用

到确认过程的严格程度将由该仪器的复杂性和预
定用途来决定。

这个

方法强调了

AIQ
在从分析仪器中获得可靠数据的全过程中
的位置。

Validation versus Qualification
验证对确认

In this chapter, the term validation is used for manufacturing
processes, analytical procedures, and software procedures and the
term qualification is used for instruments. Thus, the phrase
“
analytical instrument qualification
”
(AIQ) is used
for the process of ensuring that an instrument is suitable for its
intended application.
在此通则中，验证一词用于生产工艺、分析方法、软件程序，而确认

一词用于仪
器。因此，“分析仪器的确认” （
AIQ
）一词用于确保仪器

适用于其预定用途的
过程。

COMPONENTS OF DATA QUA
数据质量的组成部分

There are four critical components involved in the generation of
reliable and consistent data (quality data).
Figure 1
shows these
components as layered activities within a quality triangle. Each
layer adds to the overall quality. Analytical instrument


qualification forms the base for generating quality data. The other
components essential for generating quality data are analytical
method validation, system suitability tests, and quality control
checks samples. These quality components are described as below.
在产生可靠和一致的数据
(
质量数据
)
的过程中涉及了四个重要的组

成部分。
图

1
以层叠形式在质量三角形内展示了这些组成部分。

每层

相加构成了总体质量。

分析仪器确认构成了产生质量数据的基础。

作

为质量数
据产生的基础的其他组成部分为分析方法验证、

系统适用性

测试、质量控制检验样品。这些质量部分描述如下。





An alytical In strume nt Qualificati on
分析仪器确认

AIQ is the collection
of documented evidenee that an instrument
performs suitably for its intended purpose. Use of a qualified in
strume nt
in an alyses con tributes to con fide nee in the
validity of gen erated data.
AIQ
是证明某个仪器表现得适合其预定用途的文件证据的汇总。在分

析中使用确
认过的仪器确保了对所生成数据的有效性的信心。

An alytical Method Validation
分析方法验证

Analytical method validation is the collection of documented


evidence that an analytical procedure is suitable for its intended
use. Use of a validated procedure with qualified analytical
instruments provides confidence that the procedure will generate
test data of acceptable quality. Additional guidance on validation
of compendial procedures may be found in the general information
chapter
Validation of Compendial
Procedures
<1225>.
分析方法验证是某个分析方法适合其预定用途的文件证据的汇总。

使

用确认过
的分析仪器和验证过的方法确保了该方法将会产生质量可

接受的测试数据的信
心。

关于药典方法的验证方法的额外指导原则可

以在通则

药典方法的验证

<1225>
中找到。

System Suitability Tests
系统适用性测试

System suitability tests verify that the system will perform in
accordance with the criteria set forth in the procedure. These
tests are performed along with the sample analyses to ensure that
the system
'
s performance is acceptable at the time of the test.
USPgeneral chapter
Chromatography
<621> presents a more detailed
discussion of system suitability tests as related to
chromatographic systems.
系统适用性测试证实该系统的表现将会符合此方法中设定的标准。

这

些测试与
样品分析仪器进行，

从而确保此系统的表现在测试的时候是

可以接受的。
USP
通则< br>色谱法＜
621
＞
呈现了对于色谱系统的系统适用

性测试的更加具体讨论。



Quality Control Check Samples
质量控制检验样品

Manyanalysts carry out their tests on instruments standardized
using reference materials and/or calibration standards. Some
analysts also require the inclusion of quality control check
samples to provide an in-process or ongoing assurance of the test
'
s suitable performance. In this manner, AIQ and analytical method
validation contribute to the quality of analysis
before
analysts
conduct the tests. System suitability tests and quality control
checks help ensure the quality of analytical results
immediately
before
or
during
sample analysis.
许多分析员在以标准物质和

/
或校准标准品进行标准化的仪器上进行

他们的测
试。

一些分析员还要求加入质量控制检验样品，

以便对此测

试的适当表现提供
中间或持续的保证。

在这个方面，

在
分析员进行该

测试
之前
，
AIQ
和分 析方法验证就对分析质量起到了作用。系统适用

性测试和质
量控制检查，则在样品分析

马上开始之前
或在
其过程中
，

帮助确保分析结果的质量

ANALYTICAL INSTRUMENT QUALIFICATION PROCESS
分析仪器确认程序

The following sections address in detail the AIQ process. The


other three components of building quality into analytical data
analytical method validation, system suitability tests, and quality
control check samples
----------------
are not within the scope
of this chapter.
下面的章节具体解答了

AIQ
的过程。确保分析数据质量的其他
3
个组

成部分，
分析方法验证、系统适用性测试、质量控制检验样品，不在

此通则的范围之内。

Qualification Phases
确认的阶段

Instrument qualification is not a single continuous process, but
instead results from several discrete activities. For convenience,
these activities can be grouped into four phases: design
qualification (DQ), installation qualification (IQ), operational
qualification (OQ), and performance qualification
(PQ).
仪器确认不是一个单独的连续过程，而是源自若干独立活动的结果。

为方便起
见，这些活动可以被归为

4
个阶段：设计确认（
DQ
、安装

确认（（
IQ
）、运行确认（
0Q
、性能确认（
PQ
。

Some AIQ activities cover more than one qualification phase, and
analysts potentially could perform them during more than one of the


phases
（
see
Table 1
）
. However, in many instances there is need
for specific order to the AIQ activities; for example, installation
qualification must occur first in order to initiate other
qualification activities.
will be defined and documented.
一些
AIQ
活动包括了超过一个确认阶段，并且分析员倾向于可以跨阶

段进行这些
活动（见

表
1
）。但是，在很多情况下，
AIQ
活动有特定的

顺序要求；例如，安
装确认必须首先发生，以便启动其他确认活动。

The AIQ activities
AIQ
活动将被定义并以文件形式记录。

Table 1. Timing, Applicability, and Activities for Each Phase of
Analytical Instrument Qualification*


Desig n
Qualificatio

n



Prior
to
purchase of a
new model of
in strume nt



Assura nee of
manu facturer
'
s DQ


Assura nee of


In stallati on
Operati ona
Qualificati on
l
Qualificat
ion
Timing and Applicability
At installation
After
of
each
in stallati
in strume nt
on or major
(n ew, old, or
repair
of
existi ng
each
unq ualified)
in strume nt

Activitie
s
Descripti on
.

Fixed
parameters



Performa
nc
e
Qualificat
ion
Periodical
ly
at
specified
in tervals
for
each
in strume nt

Preve ntive
maintenanc
e
and
repairs
Establish



In strume nt

Instrument
'
for
s fitn ess
Utilities/fa
ci
lity

En vir
onmen t
in
use
laboratory









adequate
support
availability
from manu
facturer


Assembly
and

in stallati
on
Network
and

data storage
delivery
In stallatio n
verificati on





Secure data

storage,
backup, and
archive
—

In strume nt
fun cti on
practices
to address
operatio n,
calibratio
n,
maintenanc
e, and
change
control
—

Performa nc
e checks

tests
*Activities
under each phase are usually performed as given in
the table. However, in some cases, it may be more appropriate to
perform or combine a given activity with another phase. Such
activities, spanning more than one qualification phase are shown as
connected by double arrows. If an activity listed under a given
phase is performed under another
phase, it is not
n ecessary to repeat the activity un der the phase where the
activity is listed. Performi ng the activity is far more important
than the phase under which the activity is performed.
表
1.
分析仪器确认每个阶段的时间表、实用性、活动

设计确认

安装确认

运行确认

性能确认

时间表和实用性
在购买新型在安装每个

在每个仪器

每个仪器在



仪器之前




















确认制造商



设计确认







确认制造商


可以给与充



分支持











仪器在实验



室中使用的



适用性







仪器时
（
新

的、旧的、或

一直未经确

认
的
）


描述

仪器运送

公用设施
/
设


施




安装或大修

之后

固定参数

环境

规定的间隔

定期进行

预防性保养

和维修

设立相关规

程，以解决

操作、校准、
维护、变更

控制



活动











组装与安装


网络和数据

储存



安全的数据

储存、备份、



存档


安装确认



仪器功能测
.
性能测试


试

一

在每个阶段下的活动通常按照表中列出地进行。

可以更加适合进行或合并某个特定活动于其他阶段。

但是，在某些情况下，

这样跨域超过一

个确认阶段的活动用双箭头连接来显示。如果某个列出于特定阶段的

活动进行于
另外一个阶段，没有必要在列出该活动的阶段重复进行。

进行该活动要比该活动
在那个阶段进行重要许多。

DESIGN QUALIFICATIO
N
计确认

Design qualification (DQ) is the documented collection
activities that
defi ne
the fun cti onal and operati onal
of
specifications
of the instrument and criteria for the selection
of the ven dor, based on the inten ded purpose of the in strume nt.
Design qualification (DQ) may be performed not only by the
instrument developer or manufacturer but also maybe performed by the


user. The manufacturer is generally responsible for robust design
and maintaining information describing how the analytical instrument
is manufactured (design specifications, functional requirements,
etc.) and tested before shipment to users. Nonetheless, the user
should ensure that commercial off-the-shelf (COTS) instrument are
suitable for their intended application and that the manufacturer
has adopted a quality system that provides for reliable equipment.
Users should also determine the manufacturer
'
s capability for
support installation, services, and training. This determination
might be aided by the user
'
s previous interaction with the
manufacturer.
设计确认
(
DQ
是基于仪器预定用途，对仪器的功能与操作标准和提

供商的选取标
准做出规定的活动总汇，

并以文件记录。设计确认
(
DQ
不仅可以由仪器开发者或
制造商进行，

也可以有使用者进行。

制造商

通常负责稳健设计和维护信息，

描
述该分析仪器如何制造
(
设计标准、

功能要求等
)
在发给客户之前如何测试。虽然
如此，使用者仍应该确

保商用成品仪器适用于他们的预定用途，

并且制造商已经
采纳了能够

保证仪器可靠的质量系统。

使用者也应该确定制造商在辅助安装、

服

务、培训方面的能力。

确定的过程可以借助使用者以前与制造商的互

动交流。

INSTALLATION QUALIFICATIO
安装确认



Installation qualification
（
IQ
）
is the documented collection of
activities necessary to establish that an instrument is delivered as
designed and specified, and is properly installed in the selected
environment, and that this environment is suitable for the
instrument. IQ applies to an instrument that is new or was pre-
owned, or to any instrument that exists on site but has not been
previous qualified. Relevant parts of IQ would also apply to a
qualified instrument that has been transported to another location
or is being reinstalled for other reasons, such as prolonged
storage. The activities and documentation typically associated with
IQ are as follows.
安装确认（
IQ
）是对用于确定某个仪器按照设计和规定的方式运输并

正确安装在
选定的环境中，

以及该环境适合于此仪器所必需的活动总

汇，并以文件记录。

IQ
应用于某件仪器，其可以是新的或是二手的，

或应用于任何已经在现场但是
此前从未确认过的仪器。

IQ
的相关部

分也会用于某个已经确认的设备，

但是
该设备经过运输至另外的一个

场所或由于其他原因（例如，延长的存储）重新安
装。通常与

IQ
相

关的活动和文件如下。




Description
---
Provide a description of the instrument or the
collection of instrument components, including its manufacturer,
model, serial number, software version, and location. Use of
drawings and flow chart where appropriate.
描述

--
提供该仪器或者仪器组成部分汇总的描述，

包括其制造商、

型号、编号、软件版本、放置位置。适当情况下使用图纸和流程图。

Instrument Delivery
--- Ensure that the instrument, software,
manuals, supplies, and any other instrument accessories arrive as
specified in the purchase order and that they are undamaged. For a
pre-owned or existing instrument, manuals and documentation should
be obtained.
仪器运输

---

确保该仪器、软件、手册、供给品，以及其他仪器附

件按照订单中规定的方式抵达，

并且他们没有损坏。

对于二手或已有

的仪器，
手册和记录文件必须得到。

Utilities/Facility/Environment
-----
V
erify that the
installation site satisfactorily
environmental requirements.
meets manufacturer-specified

公用设施

/
设施
/
环境

证实安装区域令人满意地达到了制造商规


定的环境要求

Assembly
and installation
instrument
,
and perform

--

Assembly
any preliminary
and install
diagnostics
be done by
the
and
the
testing.
Assembly and
installation may
manufacturer, vendor, specialized engineers, or qualified in-house
personnel. Manufacturer-established installation tests and guides
provide a valuable baseline reference for determining instrument
acceptance. Any abnormal event observed during assembly and
installation merits documenting. Installation packages purchased
from the manufacturer or the vendor may, however, need to be
supplemented with user-specific criteria.
组装和安装

---

组装和安装仪器，并进行任何预诊断和测试。组装

和安装可以由其制造商、供应商、专业工程师、或有资质的内部员工

来进行。

对
于确定仪器的验收，

制造商确定的安装测试和指导提供了

具有价值的基本参考。

在组装和安装过程中观察到的任何异常事件均

需以文件记录。

但是，购自制造商
或供应商的安装包需要根据用户的

具体标准进行补充。

Network and Data Storage
---- Some analytical systems require users
to provide network connections and data storage capabilities at the
installation site. Whenrequired, connect the instrument to the
network, and check its functionality.
网络和数据储存

-----

一些分析系统要求使用者在安装场所提供网



络连接和数据存储能力。当需要时，将仪器连接到网络，并检查其功

Installation Verification
---- Perform the initial diagnostics
and testing of the instrument after installation.
安装认证

--
在安装之后，进行该仪器的初始诊断和测试。

OPERATIONAL QUALIFICATION
确认

After a successful IQ, the instrument is ready for OQtesting.
Operational qualification (OQ) is the documented collection of
activities necessary to demonstrate that an instrument will function
according to its operational specification in the selected
environment. Testing activities in the OQ phase consist of these
test parameters.
在成功的
IQ
之后，此仪器就可以进行

OQ
测试了。操作确认（
OQ
是

证实某个仪器将会在选定的环境中按照其操作规范运行所必需的活

动总汇，并以文件记录。在
0C
阶段的测试活动包含了这些测试参数。

Fixed Parameter
---
These tests measure the instrument
'
s


non-changing parameter such as length, height, weight, voltage
inputs, acceptable pressures, and loads. If the manufacturer-
supplied specifications for these parameters satisfy the user, the
test requirements maybe waived. However, if the user wants to
confirm the parameters, testing can be performed at the user
'
s
site. Fixed parameters do not change over the life of the
instrument, and therefore never need redetermination. [NOTE: These
tests could also be performed during the IQ phase (see
Table 1
); if
so, fixed parameters need not be redetermined as part of OQ
testing.]
固定参数

--
这些测试测量该仪器的不变参数，例如长度、高度、

重量、输入电压、可接受压力、载荷等。如果由制造商提供的这些参

数的规格令
用户满意，可以放弃测试要求。但是，如果用户需要确认

这些参数，

可以在使用
者的场地进行测试。

固定参数在仪器的寿命周

期内不会变化，并且因此不需重
测。

【注意：这些测试还可以在

IQ
阶

段
(见
表
1
)
进行；如果这样，固定参数作
为

需重测。】

0Q
测试的一部分，无

Secure Data Storage, Backup, and Archiving ----
Whenapplicable,
test secure data handling such as storage, backup, audit trails, and
archiving at the user
'
s site according to written procedures.
安全数据存储、备份、存档

------

当可行的时候，根据书面程序，在