*欧阳光明*创编 2021.03.07
OMCL Network of the Council of
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QUALITY MANAGEMENT DOCUMENT
PA/PH/OMCL (11) 04
QUALIFICATION OF EQUIPMENT
仪器确认
ANNEX 1: QUALIFICATION OF HPLC EQUIPMENT
附件1：HPLC仪器的确认
Full document title and reference 文件全名和索引号 Qualification of Equipment Annex 1: Qualification of HPLC equipment PA/PH/OMCL (11) 04 Document type 文件类型 Legislative basis 立法基础 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 May 2005 Date of first adoption 首次发行日期 Date of original entry into force 首次执行日期 Date of entry into force of revised document 修订后执行日期 Previous titles/other references 原文件名/其它索引号 Custodian Organisation 保管机构 Concerned Network June 2005 1st July 2011 This document replaces document PA/PH/OMCL (07) 17 DEF The present document was elaborated by the OMCL Network/ EDQM of the Council of Europe GEON *欧阳光明*创编 2021.03.07
*欧阳光明*创编 2021.03.07
相关网络 ANNEX 1 OF THE OMCL NETWORK GUIDELINE
“QUALIFICATION OF EQUIPMENT” OMCL网络指南“仪器的确认”之附件1 QUALIFICATION OF HPLC EQUIPMENT
HPLC仪器的确认
Introduction 概述
The present document is the first Annex of the core document
“Qualification of Equipment”, and it should be used in combination with it when planning, performing and documenting the HPLC equipment qualification process.
本文件是核心文件“仪器的确认”第1个附件，在计划、实施和记录HPLC仪器的确认过程时，应将本文件与核心文件一起使用。 The core document contains the general introduction and the Level I and II of qualification, common to all type of instruments, and the present annex contains HPLC instrument-related recommendations on parameters to be checked and the corresponding typical acceptance Limits, as well as practical examples on the Methodology that can be used to carry out these checks.
核心文件包括了第一级和第二级确认的通用介绍，适用于所有类型的仪器，本附件包括了HPLC仪器相关的需要检查的参数和相
*欧阳光明*创编 2021.03.07
*欧阳光明*创编 2021.03.07
应典型的可接受标准的推荐，以及可用于进行这此检查的实用方法学举例。
When qualifying HPLC equipment, it should be noted that it is acceptable to check at Level III and IV several of the mentioned parameters at the same time in a combined test procedure (e.g. “overall” system performance test giving information on peak area precision, retention time precision, gradient reproducibility, etc).
在进行HPLC仪器确认时，应注意也可以对第三级和第四级几个提到的参数采用联合检测程序同时进行检查（例如“全面”系统性能检查，同时给出峰面积精密度、保留时间精密度、梯度重复性等的信息）
TABLE III 表三
Level III. Periodic and motivated instrument checks
第三级定期主动仪器检查
Examples of requirements for HPLC instruments and detectors
HPLC仪器和检测器要求举例
Instrument module 仪器模块 Solvent delivery system 溶剂传送系统 Parameter to be checked Typical tolerance Limits 需检查的参数 典型允差限度 ? ±5 % ? Flow rate 流速 ? Proportioningaccuracy and ? ±2 precision (gradient test) 配比准确? ≤0.2 % 度和精密度（梯度测试） ? Proportioning ripple 配比波动 ? Volume precision 进样量精密度 ? RSD≤1.0 % ? see Annex I 见附件1 ? Carry-over 残留 Thermostatting accuracy and precision ? ±3 °C 恒温准确度和精密度 Thermostatting accuracy ? ± 2 °C Injector 进样器 Autosampler 自动进样器 Oven or cooling device *欧阳光明*创编 2021.03.07
2021年欧盟OMCL仪器确认附件1-HPLC确认
