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Network of the Council of Europe
QUALITY MANAGEMENT DOCUMENT
质量管理文件
PA/PH/OMCL (08) 73 2R
QUALIFICATION OF EQUIPMENT
仪器确认
CORE DOCUMENT
核心文件
Full document title
and reference
文件全名和索引号
Qualification of Equipment
–
Core document
仪器确认
—
核心文件
PA/PH/OMCL (08)73 2R
Guideline
指南
The present document was also accepted by EA as
recommendation document to be used in the context of Quality
Management System audits of OMCLs
Date of first
adoption
首次采用日期
Date of original
entry into force
首次生效日期
Date of entry into
force of revised
1st July 2011
1st February 2000
1st October 1999
Document type
文件类型
Legislative basis
立法基础
document
修订版本生效日期
Previous titles/other
references
曾用文件名
/
索引号
Custodian
Organisation
管理组织
Concerned Network
相关网络
GEON
The present document was elaborated by the OMCL
Network/EDQM of the Council of Europe
This document replaces document PA/PH/OMCL(08)73 R
Introduction
介绍
The standard ISO/IEC 17025 requires an appropriate choice and
qualification of equipment to be used for testing purposes. Particularly, checks
and calibrations before and during use and, if needed, intermediate tests (see
ISO/IEC 17025 chapter 5.5.10) are necessary.
ISO/IEC 17025
标准要求用于 检测的仪器应进行适当的选择和确认，
特别是
在使用前和使用中应进行检查和校正，必要时应进 行中间测试（见
ISO/ICE
17025
第
5.5.10
章节）。
In order to guarantee a harmonized interpretation and application within
the OMCL Network, the guideline ? Qualification of Equipment ? has been
elaborated.
为了保证在
OMCL
网络内的统一解释和应用，< br>特制订此指南
《仪器确认》
。
From experience, the terms DQ, IQ, OQ and PQ (not explicitly mentioned
by ISO/IEC 17025) have been used in a non-harmonized way amongst the
different OMCLs. Therefore their mention has been avoided in this document.
This does not exclude their use in OMCL’s quality systems where already
approved and in application, or a reference to literature using
this
nomenclature
.
根据经验，术语
DQ, IQ, OQ
和
PQ
（在
ISO/IEC 17025
中未明确提出）已由非协调方式在不同
OMCL
中采用，因此在本文中避免对这些术语的使用。但
这 并不排除
OMCL
的质量体系在已批准和实际中采用这些术语，或者引用一些
使用了这 些术语的文献。
In order to simplify the management of the guideline, the present
document contains only the general introduction and the first two levels of
qualification, which are common to all type of equipment. The third and fourth
levels of qualification can be found in separate instrument- related annexes.
When considered appropriate, additional requirements and/or examples
related to Level I and/or Level II have also been included in the annexes, which
are to be used in combination with the general recommendations given in the
core document. 为了简化指南管理，
本文件仅包括通用介绍，
以及前两个级别的确认，
可以
适用于所有类型的仪器。
第三级和第四级的确认可以在单独的仪器相关的附件中
找到。考虑到 适用性，附加要求和
/
或第一级和
/
第二级的相关举例也列在了附件
中，这些内容应与核心文件中的通用推荐结合使用。
The list of annexes, included in this document, will be updated as soon as
new annexes are issued.
如有新附件增加，包括在本文件中的附件清单将同步更新。
This document should be considered as a guide to OMCLs for planning,
performing and documenting the equipment qualification process. It should not
be taken as an exhaustive list of compulsory tests. It is left to the professional
judgment and background experience of each OMCL to decide on the most
relevant tests and the most appropriate tolerance limits for each of the
parameters, in order to give evidence that the instrument is working properly
and is appropriate for its intended use.
本文件应被作为
O MCL
的指南，用于计划、实施和记录仪器确认过程。它
不应该作为一个必检内容的完全列举清 单。各
OMCL
应根据自己的专业判断和
背景经验来决定最相关的测试，
每个 参数的最合适允许限度，
以证明仪器能正常
工作，并适合适其使用目的。
If the qualification of equipment is done by the manufacturer itself or an
external service, it is under the responsibility of the OMCL to make sure that
the checks performed are in line with the minimum requirements set in this
guideline.
如果仪器的确认由供应商提供，或委托外部服务机构进行， 那么
OMCL
有
责任保证所进行的检查符合本指南的最低要求。
To facilitate the implementation of a documented qualification process for
the various analytical instruments, specific recommendations on minimum
requirements are given in the corresponding annexes.
为方便不同的分析仪器 实施和记录确认过程，
在相关的附件中给出了针对不
同仪器的推荐和最低要求。
For the more technique-related aspects of equipment qualification checks,
practical examples of possible approaches are also presented in the annexes.
对于与技术相关方面的仪器确认检查，
在附件中也给出了可 能方法的实际例
子。
The following four levels of Equipment Qualification should be considered
by the OMCLs:
OMCL
应考虑以下四级仪器确认
Level I. Selection of instruments and suppliers
第一级
仪器和供应商的选择
The selection and purchase of new instruments shall follow a conscious
decision process, based on the needs related to the intended use of the
instrument.
新仪器的选择和采购应根据仪器的用途，采用明确的决策流程，
An example for setting and documenting such specifications and
decisions taken is given in Table I.
表一给出了设置和文件的接受标准和决策的例子。
Level II. Installation and release for use
第二级
安装和放行使用
When receiving an instrument, the OMCL should check that it is received
in good conditions, as ordered, and should monitor and document the
installation process of the instrument in the selected environment. This
includes the start up checks done by the supplier, followed by a full periodic
check as described in Level III.
接收仪器时，
OMCL
应检查其处于良好状态，与订单一致，并应该监控和
记录仪器在选择的环境下进行安 装的过程，这里也包括供应商所做的开机检查，
以及在第三级检查中描述的全面周期性检查。
The release for use shall be documented and authorised by the person
responsible for the instrument.
仪器放行使用的过程应有记录，并由授权人进行放行。
An example for documenting the instrument installation and release for
use and decisions taken is given in Table II.
在表二中给出了记录仪器安装和放行使用的例子。
Level III. Periodic and motivated instrument checks
第三级
周期性主动仪器检查
When instruments are installed or moved into a new environment a series
of checks have to be carried out to verify the key performance parameters of
the instrument avoiding additional contributory effects from the analytical
method. Depending on the frequency of use and the experienced stability of
the instrument this shall be repeated periodically.
当仪器安装后，或移动至一个新的环境后，需要确认 仪器的关键性能参数，
以避免分析方法产生的附加影响。
本检查根据仪器使用的频次以及其稳定 性情况
应该周期性地重复进行。
The same verifications (or a relevant part of them) shall be carried out
following events like significant repair or maintenance operations.
当仪器在经过重大维修或维护后，
应该进 行相同的确认
（或相关部件进行确
认）。
Examples of parameters to be checked on instruments and their typical
acceptance limits can be found in the Table III of the corresponding
instrument- related annex.
在相应仪器的附件中，
表三中列出了一些仪器需要检查的参数 及其典型的可
接受标准。
The specifications from the manufacturer of the instrument should be
taken into account when setting the tolerance limits.
在设定可接受限度的时候，应考虑仪器供应商所提供的标准。
Some examples on how these checks may be performed on each type of
instrument are also provided in the corresponding Annexes.
在相应的附件中给出了记录仪器安装和放行使用的例子。
Level IV. In-use instrument checks
第四级
在用仪器检查
During the day-to-day use of the instruments, checks are necessary to
demonstrate continued evidence of satisfactory performance by the instrument
itself and compliance with the system suitability criteria as defined in the
applied analytical procedure for each product or group of products tested at
this occasion.
在仪器日常使用中，
有必要对仪器本身性能满意性进 行持续检查，
以及在此
情况下单个产品或一类产品所用方法的系统适用性检查。
Examples of parameters to be checked on instruments and their typical
acceptance limits can be found in the Table IV of the corresponding
instrument-related annex.
在相应仪器的附件表四可以找到需要检查的仪器参数及其典型可接受限度。
In the case of OMCLs performing routine testing (Type A: batch release of
vaccines and blood products), the use of control charts provides
supplementary information on equipment performance, which can also be
used in this context.
如果
OMCL
在进行常规测试（类型
A
：疫苗和 血液制品批放行），采用控
制图表所提供的仪器性能的补充信息也可以采用。
List of instrument-related annexes
仪器相关附件清单
The qualification levels dealt with in each annex are indicated in brackets.
各附件内容包括的确认级别在括号内说明
? Annex 1: Qualification of HPLC equipment (Levels III and IV)
附件
1
：
HPLC
仪器确认（第三级和第四级）
? Annex 2: Qualification of GC equipment (Levels III and IV)
附件
2
：
GC
仪器确认（第三级和第四级）
? Annex 3: Qualification of UV-Visible spectrophotometers (Levels I, III
and IV)
附件
3
：紫外
-
可见光谱仪确认（第一级、第三级和第四级）
? Annex 4: Qualification of IR spectrophotometers (Levels I, III and IV)
附件
4
：红外光谱仪确认（第一级、第三级和第四级）
? Annex 5: Qualification of automatic titrators (Levels III and IV)
附件
5
：自动滴定仪确认（第三级和第四级）
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