仪器确认 附件2 GC确认 中英文.doc
OMCL Network of the Council of Europe QUALITY ASSURANCE DOCUMENT 质量保证文件 PA/PH/OMCL (06) 86 DEF QUALIFICATION OF EQUIPMENT 仪器确认 ANNEX 2: QUALIFICATION OF GC EQUIPMENT 附件2：气相色谱仪的确认
Full document title and reference 文件全名和索引号
Qualification of Equipment Annex 2: Qualification of GC Equipment PA/PH/OMCL(06)86DEF Document type 文件类型 Guideline
Legislative basis 立法基础 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 首次发行日期 May 2006
Date of original entry into force 首次执行日期 June 2007
Date of entry into force of revised document 修订后执行日期
October 2006
Previous titles/other references 原文件名/其它索引号 This document replaces part of document PA/PH/OMCL(06)46
DEF Custodian Organisation 保管机构 The present document was elaborated by the OMCL
Network/EDQM of the Council of Europe Concerned Network 相关网络 GEON
ANNEX 2 OF THE OMCL NETWORK GUIDELINE “QUALIFICATION OF EQUIPMENT” OMCL网络指南“仪器确认”附件2
QUALIFICATION OF GC EQUIPMENT
气相色谱仪的确认 Introduction 介绍 The present document is the second Annex of the core document “Qualification of Equipment”, and it should be used in combination with it when planning, performing and documenting the GC equipment qualification process.
本文件是核心文件“仪器确认”的第二个附件，在计划、实施和记录气相色谱仪的确认时，应将本文件与核心文件联合使用。
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 GC 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.
核心文件包括了一般介绍和第一级与第二级确认，适用于所有类型的仪器，本附件包括了气相色谱仪相关的建议，包括哪些参数需要检查，相应的典型可接受标准，以及用来进行这些检查的实践方法学例子。
The tests proposed in the Level III and IV of qualification are based on an overall approach, in which several parameters are checked at the same time in a combined test procedure, to obtain information on the overall system performance (e.g. peak area precision, retention time precision, temperature programme reproducibility, etc).
在第三级和第四级确认所建议的检查是基于一种全面检查的方法，在其中同一个联合测试可以检查几个不同参数，得到全面的系统性能信息（例如峰面积精密度、保留时间精密度、温度程序重复性等）
Nevertheless, it should be noted that it is also acceptable to check these parameters individually by using other well-defined procedures.
另外，需要注意如果采用其它界定很好的程序对这些参数进行单独确认也是可以接受的。 TABLE III表3 Level III. Periodic and motivated instrument checks 第三级 周期主动仪器检查 Examples of requirements for GC instruments with FID 配备FID检测器的气相色谱仪的要求举例 Instrument module 仪器模块 Parameter to be checked 需要检查的参数 Typical tolerance limit 典型可接受限度
1 Inlet system 进样系统 1.1 Injector leak test 进样器泄漏检查 1.2 Pressure/flow accuracy and stability 压力/流速准确性和稳定性 1.3 Repeatability of injection (overall test 1) -- in split mode 分流模式 --In split less mode 分流较少模式 1.4 Injector temperature ands accuracy and stability 进样器温度 准确度和稳定性 1.5 Carry-over (overall test 3) 残留（全面检查3） Pressure drop≤15kPa Within 5 min 5分钟内压降≤15kPa Covered by overall test 1 包括在全面检查1中
RSD≤3.0% RSD≤3.0%
Covered by overall test 2 包括在全面检查2中 ≤0.2%
2. Oven 柱温箱 2.1 Repeatability of oven temperature characteristics 柱温箱温度重复性 Covered by overall test 2 包括在全面检查2中 3. FID detector FID检测器 3.1. Linearity (overall test 3) 线性（全面检查3） 3.2. Constant detector response 检测器响应恒定性 3.3 Noise噪声 3.3. Drift 漂移 r2≥0.999 covered by overall test 1 or 2 包括在全面检查1或2中 see annex 1 见附件1 See Annex 1 见附件2
TABLE IV 表四 Level IV. In-use instrument checks 第四级：在用仪器检查 Examples of requirements for GC instruments with FID 配置FID检测器的气相色谱仪为例 Parameter to be checked 需要检查的参数 Typical tolerance limits 典型可接受限度 1. System suitability check for the method 方法系统稳定性检查 According to Ph. Eur. Or MAH dossier or validated in-house method 根据EP或MAH相关文件，或内部已验证的方法 2. Peak area precision 峰面积精密度 RSD≤3.0% unless otherwise prescribed* 除另有规定外RSD≤3.0% 3. Retention time repeatability 保留时间重复性 RSD≤2.0%
4. Sensitivity (where relevant, e.g. for related substances tests) 灵敏度（如果相关，例如对于有关物质） According to Ph. Eur. or MAH dossier or validated in-house method 根据EP或MAH相关文件，或内部已验证的方法 * This is to be defined in conjunction with the target concentration of the analyte
这要与分析物的目的浓度联系起来确定。 All parameters given here should be checked when performing analyses under the working conditions for the actual sample determinations. Normally, the test and reference solutions to be prepared for this purpose are given as a part of the method.
这里给出的所有参数应在工作状态下进行实际样品检查分析时进行检查。一般来说，供试液和对照溶液应根据此目的作为方法的一部分进行准备。
欧盟OMCL仪器确认附件1-HPLC确认
OMCL Network of the Council of EuropeQUALITY MANAGEMENT DOCUMENTPA/PH/OMCL (11) 04QUALIFICATION OF EQUIPMENT仪器确认ANNEX 1: QUALIFICATION OF HPLC EQUIPMENT 附件1：HPLC仪器的确认ANNEX 1 OF THE OMCL NETWORK GUIDELINE“QUALIFICATION OF EQUIPMENT”OMCL网络指南“仪器的确认”之附件1QUALIFICATION OF HPLC EQUIPMENTHPLC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。
检验仪器检验方法验证或确认
HPLC校准项目及周期示例
校准项目 波长准确度 （低波段，咖啡因溶液） 波长准确度 （高波段，钬玻璃） 基线噪音和基线漂移
线性测试 进样精密度
国家检定 主要项目：泵流速的准确度与稳定性， 定性、定量重复性，基线噪音，基线漂 移，最小检测浓度，和柱温箱温度的准 确度。
•
第九十四条 不得使用未经校准、超过校准有效期、失准的衡器、量具、
仪表以及用于记录和控制的设备、仪器。
• 第二百二十一条 质量控制实验室应当至少有下列详细文件……7.仪器校准 和设备使用、清洁、维护的操作规程及记录。
第8讲第2部分检验仪器检验方法验 证或确认
关注点——仪器的校准与维护
• 用于实验分析的设备、仪器，测量仪表都应该进行校准，包 括简单的测量仪器如温度计，密度计，熔点仪，和复杂的分 析仪器如HPLC，TOC等，关键的设备和仪器应有预防性维 护计划。
第8讲第2部分检验仪器检验方法验 证或确认
• 性能确认（performance qualification, P Q ) • 目的是确认仪器能够按照用户需求持续运
行。在安装确认和运行确认完成后，通过 性能Байду номын сангаас认证明仪器的在正常操作环境中的 适用性。
第8讲第2部分检验仪器检验方法验 证或确认
• 性能测试： • 根据用户的使用要求，设计一个或多个测
第8讲第2部分检验仪器检验方法验 证或确认
• 系统适用性试验是液相和气相色谱 法必须的组成部分。
• 证明色谱系统在使用时满足预期的 实验要求，是对仪器性能，分析操 作，色谱柱条件及被测试样品的综 合评价。
第8讲第2部分检验仪器检验方法验 证或确认
• 主要评价指标包括：分离度（R ) ，系统精 密度（R S D ) ,托尾因—f ( T ) 等。评价指 标的标准通常来自方法确认的规定，所以 这种系统适用性试验认为是基于实验方法 的系统适用性试验，是实验方法的必要组 成。
仪器设备校准确认报告 GCMS
±0.3 u
-0.3 u
符合
≤10 %
1.1 %
符合
定量重复性:22 %
定性重复性：2.5 %
确认结论
校准结果可满足检测方法要求
确认人：
审核人：
仪器设备校准确认报告
仪器设备名称及型号 计量校准机构名称 计量校准机构授权证书号 证书编号 本次校准日期
校准证书有效性
校准依据 项目
分辨力 质量范围 信噪比 质量准确度 测量重复性 检测方法要求
ห้องสมุดไป่ตู้
气相色谱-质谱联用仪 G7000C 编号 YQ-012
北京市计量检测科学研究院
（国）法计（2012）01037 号
HA17Z-SQ010114
2017 年 5 月 25 日
计量校准机构资质在有效期内，该校准仪器在检验检测能力
范围内，此证书有效
JJF 1164-2006 台式气相色谱质谱连用仪校准规范
标准值
校准值
单项结论
W1/2＜1 u
W1/2=0.7u
符合
＞600 u
＞600 u
符合
EI:m/z=272 处 S/N＞10 EI:m/z=272 处 S/N=11 符合
检验仪器确认与验证管理规程(含表格)
文件制修订记录1.目的：确保检验结果的准确性。
2.适用范围：检测仪器、计量仪器、检验方法。
3.职责：验证小组所有成员。
4.控制要求：4.1负责部门4.1.1验证方案由验证小组负责起草。
4.1.2仪器校正由计量人员负责。
4.1.3 新仪器适用性由质量管理部负责。
4.2仪器的分类A类：不具备测量功能，通常只需校准，供应商的技术可以作为用户需求。
例如：超声波清洗机、离心机等。
B类：此类仪器具有测量功能，并且仪器控制的物理参数（如温度、压力或流速等）需要校准，用户需求一般与供应商功能标准和操作限度相同。
例如：熔点仪、分析天平、PH计、折射仪、滴定仪、干燥箱、培养箱等。
此类仪器或设备通常需要进行安装确认和运行确认，并制定相关操作、校验及维护的标准规程。
C类：此类仪器通常包括仪器硬件和其控制系统（固件或软件）用户需要对仪器的功能要求、操作参数要求、系统配置、要求等详细描述。
例如：紫外、高效液相色谱仪、气相色谱仪。
此类仪器和设备需要安装确认、运行确认、专门的性能确认，并制定相关操作、校验和维护的操作规程。
4.3验证方案验证方案由有关部门提出，质量管理部会签。
根据质量标准草案确定检查和试验范围，拟定具体的操作步骤，审批实验。
4.4仪器验证4.1 A类仪器由公司计量人员根据产品说明书进行校准，即可投入使用。
4.2 B类仪器请外部检定部门出具计量合格证书，公司内部需要进行安装确认和运行确认，旧仪器只进行运行确认即可投入使用。
4.3 C类需要外检，并出具计量合格证书，公司内部需要进行安装确认、运行确认、专门的性能确认。
4.5再验证仪器在使用一段时间后，要根据仪器类别和使用情况进行再验证、校正，已经验证的旧仪器应通过功能试验。
5.规定：仪器必须经过验证或确认后才能投入使用。
6.记录：计量器具检定申请校正记录校正记录（瓶）校正温度：水的密度：校正人：复核人：校正日期：允许值：。
气相色谱仪的确认(3Q)
气相色谱仪的确认本仪器为气相色谱仪，专供测定原辅料的含量、杂质、水分和产品残留溶媒等之用.由机箱、双填充柱进样器、毛细管分流进样器、全套填充柱及毛细管载气和辅助气路、微机温度控制器、热导池检测器(TCD)、氢火焰离子化检测器(FID)、微电流放大器、工作站和色谱柱等部件组成.二.安装确认（IQ）（1）参加人员：（2）检查清单服务单位名称：地址：邮编：联系人：电话号码：传真号码：(4) 结论：所有物品与检查清单相符.化验室水、电、气设计安装合理，化验室通风系统运行良好，符合仪器安装要求.签名/日期：三.运行确认（OQ）目的为在不使用任何试样的前提下，确认该仪器达到设计要求.（1）试验项目及限度运行确认的试验项目及其限度1.载气流速稳定性检查选择适当的载气流速，待稳定后，用流量计测量，连续测量6次，其平均值的相对标准偏差不大于1%.载气流速稳定性检查记录2.柱温温度稳定性检查把铂电阻温度计的连线连接到数字多用表上，然后把温度计的探头固定在柱温中部，设定柱温温度为70℃.加热升温，待温度稳定后，观察10min，每变化一个数记录一次，求出数字多用表最大值与最小值所对应的温度值.其差值与10min内温度测量的算术平均值的比值，即为柱温温度稳定性.柱温温度稳定性记录3.程序升温重复性检查按1的检定条件和检定方法进行程序升温重复性检定.选定初温50℃，终温200℃.升温速率10℃/min左右.待初温稳定后，开始程序升温，每分钟记录数据一次，直至终温稳定.此实验重复2~3次，求出相应点的最大相对偏差，其值应≤2%.结果按右式计算：相对偏差=（t max-t min）/t平均*100%式中：t max-----相应点的最大温度（℃）；t min----相应点的最小温度（℃）；t平均----相应点的平均温度（℃）.程序升温重复性检查记录4.衰减器换档误差检查在各检测器性能检定的条件下，检查与检测器相应的衰减器的误差.待仪器稳定后，把仪器的信号输出端连接到数字多用表上，在衰减器为1时，测得一个电压值，再把衰减置于2，4，8---直至实际使用的最大档，测量其电压，相邻二档的误差应小于1%.衰减器换档误差检查记录5.1 TCD基线噪声和基线漂移检查●液体检查：色谱柱，毛细柱：0.32mm口径.载气：N2或H2●载气流速：30~60ml/min，柱温：70℃气化室：120℃●检测室温度：100℃选择灵敏档，设定桥流或热丝温度，待基线稳定后，调节输出信号至记录图，记录基线半小时，测量并计算基线噪声和基线漂移.5-2 灵敏度检查按5-1的检查条件，待基线稳定后，用校准的微量注射器，注入1～2ul浓度为5mg/ml或50mg/ml 的苯-甲苯溶液，连续进样6次，记录苯峰面积.计算公式如后：S TCD=AF C/W式中：S TCD–TCD灵敏度（mV.ml/mg）；A----苯峰峰面积算术平均值（mV.min）；W---苯的进样量（mg）；F C---校正后的载气流速（ml/min）.灵敏度检定记录6-1基线噪声和基线漂移检查●液体检定：色谱柱，毛细柱：0.32mm口径.载气：N2或H2载气流速：50ml/min，燃气：H2流速适当助燃气：空气流速适当●柱温：160℃气化室：230℃●检测室温度：230℃选择灵敏档，点火并待基线稳定后，调节输出信号至记录图，记录基线半小时，测量并计算基线噪声和基线漂移.按6-1的检查条件，待基线稳定后，用校准的微量注射器，注入1～2ul 浓度为100ng/ul 或1000ng/ul 的正十六烷-异辛烷溶液，连续进样6次，记录正十六烷峰面积. 计算公式如后：D FID =2NW/A式中：D FID –FID 检测限（g/s ）；A----正十六烷峰峰面积算术平均值（A.s ）； W---正十六烷的进样量（mg ）； N---基线噪声（A ）.检测限检查记录7定量重复性检查使仪器处于正常工作状态，注入适当的标准溶液或稳定的待分析样品，记录峰面积，连续测定6次，定量重复性以溶质峰面积测量的相对标准偏差RSD 表示，以下式计算： RSD=[∑（X I -X平均）2/(n-1)]0.5/X平均×100%式中：X I ——第i 次测得的保留时间或峰面积X 平均——n 次测量结果的算术平均值 I ——测量序号 n ——测量次数7-1 TCD 定量测量重复性的检查的记录7-2 FID定量测量重复性的检查的记录在试验进行前，均需进行系统适用性试验，应符合中国药典的要求.每隔一段时间需对此仪器进行例性维修，以确保其符合要求. （1）内容（表11）。
中国GMP附录-确认和验证-中英
附件1Annex 1确认与验证Qualification and Validation（征求意见稿）(Draft for Comments)第一章范围Chapter One Scope第一条本附录适用于《药品生产质量管理规范》中涉及的所有确认与验证活动。
Article 1 This appendix applies to all qualification and validation activities involved in Good Manufacturing Practice.第二章原则Chapter Two Principles第二条企业应当确定需要进行的确认或验证工作，以证明有关操作的关键要素能够得到有效控制。
确认和验证的范围和程度应根据风险评估的结果确认。
确认与验证应当贯穿于产品生命周期的全过程。
Article 2 A manufacturer should determine the required qualification or validation activities to prove that the critical aspects of relevant operations can be effectively controlled. The scope and extent of qualification and validation should be determined based on risk assessment results. Qualification and validation activities should be throughout the entire life cycle of a product.第三章验证计划Chapter Three Validation Plan第三条所有的确认与验证活动都应当事先计划。
确认与验证的关键要素都应在验证总计划或同类文件中详细说明。
检验仪器确认管理规程
检验仪器确认管理规程目的：建立实验室检验分析仪器确认管理规程，确保实验室仪器设备安装使用规范、科学，能够提供准确可靠的实验数据。
适用范围：实验室的检验分析仪器和设备责任人：质量管理部主任、检验员内容：1检验仪器设备的分类及要求：（依据实验室的使用需求确定仪器的类别，见附表实验室仪器和设备分类表）A类：不具备测量功能，通常只需要校准，供应商的技术标准可以满足需求；例如：超声波，离心机，电热板等。
一般通过肉眼观察，需要有正式的观察记录。
B类：仪器具有测量功能，仪器控制的物理参数（如温度，压力或流速等）需要校准；例如：熔点仪，分析天平，pH计，滴定仪，干燥箱等。
此类仪器或设备通常需要进行安装确认和运行确认，并制定相关操作、校验及维护的标准规程。
C类：仪器包括硬件和控制系统（固件或软件），需要对仪器的功能要求、操作参数、系统配置等详细描述。
例如：紫外分光光度计，高效液相色谱仪，气相色谱仪，恒温恒湿箱，红外光谱仪等。
此类仪器和设备需要安装确认，运行确认和专门的性能确认，并制定相关操作、校验和维护的标准规程。
2确认方案：在确认实施前，应由确认负责人编写方案。
确认方案应对确认各个阶段（设计确认，安装确认，运行确认和性能确认）的要求进行规定，C类仪器应准备单独的确认方案；简单仪器，所有阶段可以包含在同一个方案中。
确认方案中，应对仪器的使用目的，主要功能，关键构造进行描述，详细定义需要确认的项目、测试程序和接受标准，通常确认方案要包括以下内容：确认目的；确认过程的职责；仪器介绍，包括仪器的生产商，型号，序列号，操作系统，关键构造和主要功能；设计确认的程序和接受标准；安装确认的程序和接受标准；运行确认的程序和接受标准；性能确认的程序和接受标准；仪器的校准要求；确认过程的培训，包括使用，校准和维护的培训；相关SOP的制定，包括仪器操作，校准和维护标准操作规程；确认过程中偏差的处理；确认报告的编写。
3安装确认（IQ）：提供文件性的证明，用以确认仪器室按照规定的仪器安装的，并且安装环境满足运行要求。
GMP附件2确认与验证
附件2
确认与验证
第一章范
第一条本附录适用于在药品生产质量管理过程中涉及的所有确认与验证活动。
第二章原
第二条企业应当确定需要进行的确认或验证工作，以证明有关操作的关键要素能够得到有效控制。
确认和验证的范围和程度应根据风险评估的结果确认。
确认与验证应当贯穿于产品
第三章
第三条所有的确认与验证活动都应当事先计划。
确认与验证的关键要素都应在验证总计划
第四条验
（一）确认与验证的基本原则；
（四）确认或验证方案、报告的基本要求；
— 9 —。
实验仪器名称中英文对照表
实验仪器名称中英文对照表仪器中文名称仪器英文名称英文缩写原子发射光谱仪Atomic Emission Spectrometer AES电感偶合等离子体发射光谱仪Inductive Coupled Plasma Emission Spectrometer ICP 直流等离子体发射光谱仪Direct Current Plasma Emission Spectrometer DCP紫外-可见光分光光度计UV-Visible Spectrophotometer UV-Vis微波等离子体光谱仪Microwave Inductive Plasma Emission Spectrometer MIP原子吸收光谱仪Atomic Absorption Spectroscopy AAS原子荧光光谱仪Atomic Fluorescence Spectroscopy AFS傅里叶变换红外光谱仪FT-IR Spectrometer FTIR傅里叶变换拉曼光谱仪FT-Raman Spectrometer FTIR-Raman气相色谱仪Gas Chromatograph GC高压/效液相色谱仪High Pressure/Performance Liquid Chromatography HPLC离子色谱仪Ion Chromatograph凝胶渗透色谱仪Gel Permeation Chromatograph GPC体积排阻色谱Size Exclusion Chromatograph SECX射线荧光光谱仪X-Ray Fluorescence Spectrometer XRFX射线衍射仪X-Ray Diffractomer XRD同位素X荧光光谱仪Isotope X-Ray Fluorescence Spectrometer电子能谱仪Electron Energy Disperse Spectroscopy能谱仪Energy Disperse Spectroscopy EDS质谱仪Mass Spectrometer MSICP-质谱联用仪ICP-MS ICP-MS气相色谱-质谱联用仪GC-MS GC-MS液相色谱-质谱联用仪LC-MS LC-MS核磁共振波谱仪Nuclear Magnetic Resonance Spectrometer NMR电子顺磁共振波谱仪Electron Paramagnetic Resonance Spectrometer ESR极谱仪Polarograph伏安仪Voltammerter自动滴定仪Automatic Titrator电导仪Conductivity MeterpH计pH Meter水质分析仪Water Test Kits电泳仪Electrophoresis System表面科学Surface Science电子显微镜Electro Microscopy光学显微镜Optical Microscopy金相显微镜Metallurgical Microscopy扫描探针显微镜Scanning Probe Microscopy表面分析仪Surface Analyzer无损检测仪Instrument for Nondestructive Testing物性分析Physical Property Analysis热分析仪Thermal Analyzer粘度计Viscometer流变仪Rheometer粒度分析仪Particle Size Analyzer热物理性能测定仪Thermal Physical Property Tester电性能测定仪Electrical Property Tester光学性能测定仪Optical Property Tester机械性能测定仪Mechanical Property Tester燃烧性能测定仪Combustion Property Tester老化性能测定仪Aging Property Tester生物技术分析Biochemical analysisPCR仪Instrument for Polymerase Chain Reaction PCRDNA及蛋白质的测序和合成仪Sequencers ａnd Synthesizers for DNA ａnd Protein 传感器Sensors其他Other/Miscellaneous20升不锈钢自动发酵罐20-litre stainless automatic fermentor300升不锈钢自动发酵罐300-litre stainless automatic fermentor80升不锈钢自动发酵罐80-litre stainless automatic fermentorDNA测序仪DNA sequencerDV800核酸/蛋白分析仪Nucleic acid protein analyzerPCR操作台PCR chamberPX2多用途PCR仪Multi-purpose PCR equipmentRCCS-批量式旋转细胞培养系统Rotary cell culture system氨基酸分析仪Amino acid analyzer氨基酸自动分析仪Auto amino acid analyzer比浊仪Turbidity comparator不锈钢板式滤器Stainless steel filter超级潜水电泳仪submarine electrophoresis unit超滤器Ultra filter ａnd 4 pieces of filtration垂直电泳系统vertical electrophoresis system超声波细胞破碎仪Ultrasonic Cell Disruption System成像检测系统Chemiluminescent detection system程序降温仪Programmable controlled rate cell freezing system垂直电泳装置Clamping frame ａnd electrode assembly for vertical electrophoresis 粗纤维测定仪Equipment for Raw Fiber determination单杯药物溶出仪Single cup diffusion meter蛋白纯化交换柱盒Protein purification sample set蛋白纯化系统Protein Purification System蛋白核酸分析仪Protein nucleic acid spectrophotometer蛋白快速纯化工作站Protein purification apparatus等电聚焦电泳仪Protein isoelectric system等电聚焦双向电泳系统Isoelectric focal bidirection electrophoresis电化学工作站Electrochemical workstation电击转化仪Pulse cell transfection system电激转化仪Electroporation instruments电洗脱电泳槽Electro-eluter电细胞融合仪Cell electro fusion device电泳槽Electrophoresis cells电泳系统Electrophoresis system电泳系统2-D electrophoresis apparatus电泳仪electrophoresis System电转膜系统Mini transfer tank for electrophoresis动物细胞培养反应器Animal cell bioreactor多肽合成仪Peptide synthesis apparatus多用蛋白电泳仪Horizontal vertical electrophoresis多用途PCR仪Multifunctional PCR二维图象分析仪Spectral bio image system发酵罐Fermentation system防震台High performance lab table for microscope干胶仪Gle dryer核酸提取仪Nucleic Acid isolation machine基因扩增仪PCR基因枪Particle delivery system （PDS）近红外成分分析仪Near-infrared content analyzer拉制仪Glass Microelectrode puller连续黏度计continuous流式CELL分析仪Flow cytometer脉冲电泳槽Pulse field electrophoresis cell脉冲电泳仪Pulse field electrophoresis spectrometer毛细管电色谱仪Capillary Electropharesis Spectramete毛细管电泳分析仪Capillary electrophoresis apparatus毛细管电泳系统Capillary electrophoresis system毛细管电泳仪Capillary electrophoresis.酶标仪Micro plate spectrophotometer酶标仪Automatic microplate reader酶标仪Micro plate reader膜片钳系统Patch clamp system凝胶成相系统Gel imaging system凝胶染色系统Gle stainer system凝胶渗透色谱仪Gel permeation chromatograph抛光仪Microforge切片转移装置Section transfer system全波长扫描酶标仪Pan-wavelength micro plate reade全湿电转移装置Tank transfer unit全自动DNA测序仪（配套软件）DNA sequencer全自动DNA遗传分析仪Genetic analyzer全自动氨基酸分析仪Automatic Amino acid analyzer全自动多功能化学发光分析系统Automatic multifunction chemiluminescent analysis system 全自动多功能酶标仪Automatic microplate reader全自动发酵罐Automatic fermenter全自动固相萃取系统Automatic solid phaseextract system全自动菌落计数仪Colony Counter全自动凝胶成像分析系统Gel image analyzing system染色体自动识别分析测试系统Genetic workstation三升六联自动发酵罐3-litre hexa-automatic fermentor实时荧光定量PCR系统Real-time Fluorescence实验常用电泳仪electrophoresis System视频导电仪Electroencephalograph数码凝胶成像分析系统Digital gel image analysis system双相电泳槽Protein 2-D electrophoresis双向电泳系统Isoelectric Focusing system双向电泳仪Double-direction electrophoresis spectrometer水平程序控制电极拉制器Horizontal programmed puller索式抽提仪Soxhlet extractor梯度PCR仪Gradient thermal cycler（PCR）通用酶标仪Universal microplate reader微电极操纵器Pulse motor microdrive微电脑酸度计Micro-computer acidometer微电泳仪Micro electrophoresis微机化多功能电化学分析仪Computerized electrochemical analyzer微生物快速自动鉴定系统Auto identification system for Microorganism洗板机plate cleaning instrument细胞融合仪Cell fusion System细胞遗传学工作站Cytogenetics workstation纤维提取器Cellulose extractor小动物行为活动记录分析系统Video camera ａnd analysis system for animal observation 小型垂直电泳vertical electrophoresis unit小型双垂直电泳槽Mini double-sided vertical cell序列分析电泳系统nucleic acid sequencing system液氮罐Cryobiolgical inventory system遗传分析仪Genetic analyzer荧光定量PCR Fluorescence quantitatiye PCR原位灭菌实验室级发酵设备Laboratory Fermenter真空浓缩机Speed vacuum concentration apparatus转移电泳槽Trans-blot transfer紫外交联仪Cross linking machine（UV）自动堆码器及培养基制备系统Auto agar culture apparatus自动微量注射器Auto-micro injector最新荧光酶标仪Fluorescence microplate reader高速离心机High Speed Centrifuge荧光分光光度计Fluorescence SpectrophotometerKX-21全自动血液分析装置KX-21 The full-automatic blood analyzes to equip KX-21 SQUID高精度磁学测量系统SQUID MagnetometerXRD粉末衍射仪X-Ray Diffraction Meter一氧化碳分析仪Portable IR CO Analyzer三用紫外分析仪（暗箱式三用紫外分析仪）Tripurpose ultraviolet analyzer （Dark-box Triusage Ultraviolet Analysis Instrument）大流量TSP采样器Grate flow TSP sampling instrument小型台式离心机Benchtop Centrifuge双向电泳2-D electrophoresis system双垂直电泳槽（两种电泳槽及配套电泳仪）Vertical Electrophoresis Tanks （Two Electrophoresis Tanks with an Electrophoresis Meter）双波长飞点扫描分析仪Dual-wavelength Flying Spot Scanner双波长飞点薄层扫描仪dual-wavelength flying spot TLC scanning instrumater双稳定时电泳仪及电泳槽Electrophoresis Meter with Electrophoresis Tanks心理CT Psychology Computer Test System心理测试软件系统Psychology Test Software气相色谱-质谱联用仪GC-MS气象色谱仪Gas Chromatography水质监测仪Water quality monitor水浴摇床Water Baths Shaker加热磁力搅拌器Magnetic Stirring Apparatus半自动生化分析仪Semiautomatic biochemistry analyzer半微量电子分析天平Analytical semi-micro-balance可见风光光度计VIS Spectrophotometer四通道血凝仪 4 channels blood coagulometer生化培养箱Biochemical生化培养箱Biochemisty Incubators生物制品冷藏柜及真空干燥器（低温培养箱）ICP-incubator cooled with process controller 生物制品冷藏柜及真空干燥器（真空干燥箱2）V acuum drying oven电子天平Electronic balance电化学工作站Work station for electric chemistry电化学分析系统（恒电位仪）Electrochemical Analysis System （potentiostat / galvanostat）电动搅拌机Agitator电泳仪Electrophoresis电热恒温培养箱Electro- thermal incubator电热恒温鼓风干燥箱Electro- thermostatic blast oven电热鼓风干烘箱Lab Oven电感耦合等离子体发射光谱仪Simultaneous Inductively Coupled Plasma Atomic Emission Spectrometer（ICP—OES）石墨炉原子化器Graphite furnace atomizer光谱仪用灯Spectrum Instrument Lamp全功能型稳态瞬态荧光光谱仪Combined Time Resolved&Steady State Fluorescence Spectrometer全自动生化分析仪Automatic biochemical analyzer全自动免疫组化染色系统Autostainer Universal Staining System全自动界面张力仪Automatic tension apparatus全自动遗传分析系统（遗传分析系统）Automated Genetic Analysis System全自动酶标检测仪Auto ELISA detecter冰箱（无霜）Refrigerator （Frost Free）同步热分析仪Simultaneous Thermal Analysis扫描探针显微镜Scanning probe microscope红外干燥箱Infrared Oven红外分光光度计Infrares spectrophometer红外快速煤质分析仪Computer Ir Celerity coal Analysis Instrument自动双重纯水蒸馏器Automatical Double Pure Water Distillatory自动电位滴定仪Automatic Titrimeter自动血球计数仪automatic Blood Cell Counter血液生化分析仪blood biochemical analyzer行星式和膏机Material mixer低速大容量离心机Low Speed Large Capacity Centrifuge事件相关诱发电位仪Event related evoked potentials equipment事件相关诱发电位仪Event related evoked potentials equipment实验室用制冰机Ice Machine for Laboratory昆虫触角电位测量系统Insect tactile electromagnetic wave analyzer表面吸附仪Surface ａnd aperture meter表面活性测定仪Exterior Live Determiner便携式脑电图机32ch Digital EEG System哈氏可磨性指数测定仪Milling Exponent Determiner差热热重同步分析仪TG/DTA meter恒温振荡培养器Thermostatic oscillation incubator荧光分光光度计Spectrofluorometer荧光分光光度计Fluorescence Spectrophotometer荧光光度计Fluorescence Photometer荧光酶标仪Microplate System原子吸收分光光度计Atomic Absorption Spectrometer火焰分光光度计Flame Emission Spectrophotometer核酸蛋白纯化系统Nucleic Acid Auto-purification System核酸提取仪6100 Nucleic Acid PrepStation真空干燥箱Vacuum Drying Apparatus机械真空泵Vacuum Pump真空磁悬浮熔炼炉Vacuum induction levitation melting furnace真空磁控溅射系统Vacuum evaporative sputtering machine胶质量指数测定仪Colloid Quality Exponent Determiner高效毛细管电泳仪High Efficiency Capillary Electrophoresis高速冷冻离心机high-speed refrigerated centrifuge（used for the laboratory）偏振赛曼原子吸收分光光度计Polarization Atomic Absorption Spectrophotometer 超低有机物型超纯水机Ultrapure Water Machine二氧化碳培养箱CO2 INCUBATORS高速冷冻多功能离心机High speed refrigerated multifunction centrifuge吹扫气体发生器FT-IR Purge Gas Generator制冰机System ice model旋转蒸发器Rotary Evaporators傅立叶变换红外光谱仪FTIR spectrometer喷雾干燥机Spray Dryer循环水式多用真空泵V acuum Pump with Circulated Water System智能灰熔点测试仪Intellectual Ash Melting Point Test Instrument智能液化硫测定仪Fludified Sulfur Determiner温冰箱Low temperature refrigerator焦炭反应性测定仪Coke Reaction Determiner紫外/可见/近红外分光光度计UV-Visible-NIR Spectrophotometer紫外分光光度计UV Spectrophotometer紫外可见分光光度计UV/VIS spectrophotometer紫外光栅分光光度计VIS Spectrophotometer超级恒温水浴Super ThermostaticWater-bath超声波细胞粉碎机Ultrasonic Cell Crusher超纯水系统Ultra Purified Water System超纯水系统Hyperpure water system超滤装置（含超滤膜）Ultrafilaer Instrument微孔板液闪发光计数仪Gradient Thermal Cycler微机控压密闭消解系统Microvave Digestion System微颗粒测定仪Micro particulate monitor数字图象分析系统Micro-image analysis system数字显示旋转蒸发仪（垂直冷凝）Digital rotary evaporators （vertical condenser）瑞士梅特勒电位滴定仪（全自动多管电位滴定仪）Potential Titrator （Flexible Dual Driver General Autotitrator）熔点仪Melting Point Apparatus磁力恒温搅拌器Stirring hot plate精密电子天平Precision electronic balance精密型便携式电导仪Conductivity Meter膜片钳微操纵器Patch-Clamp Micromanipulators膜片钳灌流系统Patch Clamp Bath Perfusion System酶标仪Microplate Reader酸度计pH Meter膳食纤维测定仪Dietary Fiber Determination System薄层色谱扫描分析仪Thin-layer chromatogram流动分析与过程分析Flow Analytical ａnd Process Analytical Chemistry气体分析Gas Analysis基本物理量测定Basic Physics样品处理Sample Handling金属/材料元素分析仪Metal/material elemental analysis环境成分分析仪CHN Analysis发酵罐Fermenter生物反应器Bio-reactor摇床Shaker离心机Centrifuge超声破碎仪Ultrasonic Cell Disruptor超低温冰箱Ultra-low Temperature Freezer恒温循环泵Constant Temperature Circulator超滤器Ultrahigh Purity Filter冻干机Freeze Drying Equipment部分收集器Fraction Collector氨基酸测序仪Protein Sequencer氨基酸组成分析仪Amino Acid Analyzer多肽合成仪Peptide synthesizerDNA测序仪DNA SequencersDNA合成仪DNA synthesizer紫外观察灯Ultraviolet Lamp分子杂交仪Hybridization OvenPCR仪PCR Amplifier化学发光仪Chemiluminescence Apparatus紫外检测仪Ultraviolet Detector电泳Electrophoresis酶标仪Microplate Reader 或（ELIASA）CO2培养箱CO2 Incubators倒置显微镜Inverted Microscope超净工作台Bechtop流式细胞仪Flow Cytometer微生物自动分析系统Automatic Analyzer for Microbes生化分析仪Biochemical Analyzer血气分析仪Blood-gas Analyzer电解质分析仪Electrolytic Analyzer尿液分析仪Urine Analyzer临床药物浓度仪Analyzer for Clinic Medicine Concentration血球计数器Hematocyte Counter菌落计数仪Colony counters恒温·干燥器/恒温恒湿器Drying Ovens/Humidity Chambers送风定温恒温器Forced Convection Constant Temperature Ovens惰性气体恒温器Inert Gas Ovens精密恒温器Precision Constant Temperature Ovens洁净恒温器Clean Ovens送风定温干燥器Forced Convection Constant Temperature Drying Ovens 空气幕送风定温恒温器Forced Convection Ovens With Air Curtain定温干燥箱Constant Temperature Drying Ovens角形真空定温干燥器Vacuum Drying Ovens恒温恒湿器Constant Temperature ａnd Humidity Chambers流水线设备In-Line System for Underfill Adhesive ａnd Encapsulatio恒温培养器Constant Temperature Incubators－－-可程式低温培养器Low Temperature Program Type Incubators低温培养器Low Temperature Incubators低温稳定性培养器Low Temperature Stability Incubators培养器IncubatorsCO2培养器CO2 Incubators振荡培养器Shaking Incubators冻结干燥器Freeze Dryers－－-冻结干燥器Freeze Dryers离心形冻结干燥器Centrifugal Freeze Dryers灭菌器Sterilizers－－-干热灭菌器Drying Sterilizers高压灭菌器Autoclaves Sterilizers低温等离子灭菌器Low Temperature Plasma Sterilizers环形燃烧管灭菌器Loop Cinerator纯水制造装置Water Purifiers－－-纯水制造装置Water Stills超纯水制造装置Ultra-pure Water Purifiers简易纯水制造装置Water Purifiers超纯水制造装置系统Ultra-pure Water Purifier System大容量纯水制造装置Water Purifiers System洗净器Washers－－-实验室玻璃器皿清洗机Laboratory Glassware Washers超声波清洗机Ultrasonic Cleaners大型超声波清洗机Aqueous Ultrasonic Cleaning Systems超声波试管清洗机Ultrasonic Pipet Washers超声波清洗机Ultrasonic Cleaners恒温液槽Constant Temperature Baths－－-投入式恒温装置Constant Temperature Devices油槽Oil Baths振荡式低温水槽Low Constant Temperature Shaking Baths深槽形恒温水槽Constant Temperature Water Baths粘度测定槽Kinematic Viscosity Baths液压式恒温水槽Constant Temperature Water Baths精密低温恒温水槽Precision Low Constant Temperature Water Baths 低温恒温水槽Low Constant Temperature Water Baths试验管加热板Heating Blocks冷却液体循环器Cooling Liquid Circulators冷却水循环器Cooling Water Circulators便携式冷却器Immersion Cooler寒流捕获器Cooling Trap冷却水外部循环器Cooling Water Circulators试验槽Thoughs高温炉High Temperature Furnaces Heating Apparatus－－-马弗炉Muffle Furnaces超高温电气炉Ultra-High Temperature Electric Furnaces高温电气炉High Temperature Electric Furnaces真空气体置换炉Gas Replacement Vacuum Furnaces造粒干燥装置Granulating ａnd Drying Apparatus for Wet Powder Body ａnd Liquid－－-喷雾干燥器Spray Dryer有机溶剂喷雾干燥器Spray Dryer生产线喷雾干燥器Spray Dryer for Product Line浓缩器Evaporators－－-旋转蒸发仪Rotary Evaporators溶媒回收装置Solvent Recovery Unit乳化·搅拌·振荡器Homogenizers, Stirrers, Shakers－－-磁力搅拌器Magnetic Stirrers加热板Hot Plates振荡器Shakers送液·减压·加压装置Aspirators, Pumps, Compressors搅拌器Stirrers实验室自动乳钵Laboratory Mill/Universal Ball Mill粉碎器Cutting Mills生命科学关连仪器Life-Science Related Instruments生物技术关连仪器·食品分析仪器Bio-Technology Related Instruments, Food Analysises Instruments—形态观察分析系统Mapping Analyzer生物分子间相互作用分析系统Biomioleculer Interaction Analysis System高速液相色谱仪LC-CE/CEC System血管壁细胞混合培养系统Dynamic Coculture System动植物破碎机基因检查仪器Genopattern AnalyzerATP测定器ATP Measuring Instrument分光光度计Microplate Spectrophotometer细胞培养·发酵用自动分析系统Automated Chemistry Analyzer for Monitoring Cell Culture ａnd Fermentation Processes细胞生死判别系统Cell Vital Analyzer细胞计数分析装置Cell Scaler/Analyzer2元电泳仪荧光Spot Cutter高速冷却离心机High Speed Refrigerated,Centrifuges微量高速离心机High Speed micro-Centrifuges液体中微生物简单测试仪Simple Germ Test Kit “simple Tester”试料混合器Blender防爆冷藏柜Explosion proof Freezer ａnd Refrigerator杀菌水生成系统Sterilization Water Production Device膜式脱气装置Filter-type Air Extractor抗酸化机能水制造装置Acid-Resistant Water Purifier高性能净水器反渗透式高性能净水器分析仪器Analytical Instruments－－-分光光度计Spectrophotometer元素分析装置Atomic Absorption SpectrophotometerICP发光分光分析ICP Atomic Emission SpectrophotometerX线光分析计X-Ray Fluorescence Analysis气体分析计Gas Analyzers回折/散乱式粒度分布测定装置Analyzer,Particle Size Distribution Laser Diffraction Device低真空走查电子显微镜Scanning Probe Micro Scope高速液相色谱仪Liquid Chromatograph滴定装置Automatic Titration大塚电子制品电位计膜厚计散乱光光度计LCD测定·评价装置热量计天平Balances物性试验·测定器Physical Properties Measuring Apparatus, Testing, ａnd Measuring Apparatus －－-近红外分析装置Fourier Transform Near Infrared Spectrometer融点测定仪Melting Point Measuring Instrument热分析系统Thermo System自动反应装置Automatic Reactor水分计Moisture Analyzer引张压缩试验机Tester,Tension ａnd Compression数字粘度计Digital Viscometer振动式粘度计Vibro Viscometer浸透压测定装置Osmotic Pressure Meters超临界水酸化系统Small SCWO Systems重金属排液处理装置Heavy Metal Eliminator简易水质检查试验纸Water Quality Tester StripsPH计Phmeter导电率计Conductivity Meters湿度计Hygrothermometers过滤器Filter试验研究设备Laboratory Design ａnd Engineering－－-通风柜Fume Hoods排风机Blowers实验台Laboratory Furniture保管柜Storage Cabinets实验台用附属器具Carts ａnd Laboratory Table Attachments环境制御设施Research Facilities, Product Lines, Environment control Devices－－-生物安全柜Biohazard Safety Equipment废水处理系统Waste Water Treatment试验动物饲养室Bio Clean Room for Animal experiment环境实验设施Research Facilities, Product Lines, Environment Experiment Facilities－－-电磁波室隔音室恒温室/恒温恒湿室Constant Temperature ａnd Humidity Facilities低温室Constant Low Temperature Facilities人工气候室Artificial Atmospheric Phenomena Simulator动物研究用高压蒸汽灭菌装置Sterilization Systems, for Animal Research。
设备确认操作规程(英文)
PURPOSE:To provide a formal methodology to be followed during qualification of equipment.SCOPE:Applicable to qualification of new equipment, re-qualification of equipment, which has undergone major modification, relocation of equipment and Periodic Qualification as per schedule in Pharma manufacturing department.RESPONSIBILITY:Production, Engineering, Safety, Quality Control and Quality Assurance staff. DEFINITION:Qualification: Documented verification that the environment and equipment are appropriate for the designated function.User Requirement Specification (URS): A Requirement specification that describes what the equipment or system is suppose to do, thus containing at least set of criteriaor conditions that have to be met.Functional Design Specification (FDS): Functional design specification is a document that specifies in a complete, precise, variable manner, the requirement design, behaviour or other characteristics of a system or component and often the procedures for determining whether these provisions have been satisfied.Specification that is offered by manufacturing based on URS and are agreed mutually. Design Qualification (DQ): Formal and systematic verification that the requirements defined in the specification phase are completely covered by the succeeding specification or implementation phase.Factory Acceptance Test (FAT): Testing conducted at the suppliers factory to determine whether or not a system specifies it‟s acceptance criteria and to enable the user to determine whether or not to accept the system.Installation Qualification (IQ): Documented verification that a system is installed according to written and pre-approved specifications.Site Acceptance Test (SAT): An acceptance test at the users site, usually involve the supplier.Operation Qualification (OQ): Documented verification that a system operates according to written and pre-approved specification throughout all specified operating ranges.PLC Validation: Documented verification that PLC Hardware are as per original drawing, Digital and Analog Input and Output are connected as per PLC Architecture and functioning according to written and pre-approved specification throughout all specified operating ranges.Performance Qualification (PQ): Documented verification that a system is capable of performing or controlling the activities of the processes, it is required to perform or control, according to written and pre-approved specifications, while operating in its specified operating environment.User (s): The person, or persons, who operate or interact directly with the system. Supplier: Any organisation or individual contacted directly by the user to supply a product or service.Critical Equipment: The machine within a system where the malfunctioning or failure of equipment will have direct impact on product quality. Where product is in direct contact with machine body parts.Non-critical Equipment: The machine within a system where the malfunctioning or failure of equipment will not have direct impact on product quality. Where product is not in direct contact with machine body parts.1.0 HEALTH, SAFETY AND ENVIRONMENT: (对验证实施人员的HES要求)1.1 Personnel involved in qualification / re-qualification / periodic qualificationshould use appropriate personal protective equipment.1.2 Do not touch the moving parts.1.3 Electrical isolation should be done before any electric control panelverification.1.4 Read the safety instructions specified in the operation Manual of themachine to be qualified.2.0 PROCEDURE:2.1 Equipment qualification should be based on the following documents2.1.1 User Requirement Specification (URS)2.1.2 Functional Design Specification (FDS)2.1.3 Design Qualification (DQ)2.1.4 Factory Acceptance Test (FAT)2.1.5 Checklist on Receipt2.1.6 Installation Qualification (IQ)2.1.7 Operation Qualification (OQ)2.1.8 PLC Validation ( If applicable)2.1.9 Provisional Handover Certificate2.1.10 Performance Qualification (PQ)2.1.11 Handover CertificateThe flow of the equipment qualification is as followsURS → FDS → DQ → FAT → IQ → OQ → PLC Validation (if applicable)SAT→ PQ2.1.1 User Requirement Specification (URS):2.1.1.1 URS protocol should be approved by the project team(Users) members and Quality Assurance with Name, Signand Date.2.1.1.2 Following points should be considered during thedevelopment of URS.IntroductionOver viewOperation requirementsConstraintsLife cycle Glossary References Approval2.1.1.3 Each URS protocol should be allotted with a protocol no. inthe format specified below “URS/P”Where,“URS” stands for User requirement specification.“P” stands for equipment / instrument / balance / area abbreviated code.2.1.1.4 The protocol should also identify with a Version No. Wherethe version no. changes with every change in the URS.2.1.1.5 The URS protocol header should consist of the following detailsas mentioned below:Title of the URSProtocol No. Version No. DateCipla Patalganga UnitPage No.A specimen of the header is given below:2.1.2 Functional Design Specification (FDS):2.1.2.1The FDS should be the manufacturer interpretation of URS. FDS should include basic functioning of the equipment with focus on control and critical components specifications and functions.2.1.2.2 The FDS should be in the form of separate documentand should include equipment specification, P&IDdiagrams.2.1.2.3 The FDS protocol / report should be mutually approvedby the user and supplier with sufficient technical detailsbased on the techno commercial offer.2.1.2.4 The supplier is finally selected and CER is raised.2.1.2.5 Any changes made after finalisation of DQ should undergo change control procedure as per SOP CQA 06.2.1.3 Design Qualification (DQ):2.1.3.1 Design qualification should be based on the discussionbetween the supplier and the user with reference toURS / FDS.2.1.3.2 Following points should be considered during thedevelopment of design qualification.PurposeScopeResponsibilityProject requirementCritical variables to be metProcess/ Product parameters e.g. Capacity etc.cGMP considerationse.g. MOC of individual parts, finish of contact partsCritical parameters e.g. Instrumentation, limits,SafetyLocation suitabilityReferencesDocuments to be attached.Any changes made against the formally agreedparameters (Deviation if any).Justification for acceptance (if any deviation)Review (Inclusive of follow up action, if any)RecommendationSigning off2.1.3.3 Any change in DQ should be through a change controlprocedure as per SOP CQA-06 and should bedocumented.2.1.4 Factory Acceptance Test (FAT):2.4.1 The FAT should be conducted at the supplier‟s premisesunder the users supervision unless agreed upon.2.4.2 The FAT protocol / report should be prepared by the supplieras per Manufacturers format and should be submitted forapproval of user.2.4.3 The equipment should be shipped to the site only afterapproval by the user.2.4.4 The FAT protocol / report should include details of the URSand FDS.2.4.5 Any modification, changes needs during the FAT should bedocumented and intimated to the user and carried out withmutual consent.2.1.5 Checklist on Receipt:2.1.5.1 All critical parts of equipment should be checked forfinish, any damages on receipt for availability as perpacking list and order details.2.1.6 Installation Qualification (IQ):2.1.6.1 All aspects such as utility connections, location suitability,material of construction of critical parts, installation of allmonitoring, controlling, instruments and gauges includingtheir calibration and certification by supplier should bechecked and verified.2.1.6.2 During the installation qualification Area Lux level, Floordrains, piping connections , machine alignment, levelling,P& ID Diagram, Schematic, circuit diagram, tagging,wiring pheruling, pneumatic connections consideredduring design qualification are checked and verified.2.1.7 Operation Qualification (OQ):2.1.7.1 During Operation qualification the working of themonitoring and controlling instruments, gauges andsystems like PLC, switches, gauges, motors, pumps etc.are checked and certified.2.1.7.2 The parameters considered during design qualificationare checked and certified.2.1.8 PLC Validation2.1.8.1 PLC validation should be carried out by competentexternal approved agency.2.1.8.2 PLC validation should be carried out during SAT orsubsequently within three months based on level ofchecks carried out during SAT. Validation should be doneaccording to pre-approved protocol and report. Allreference instruments being used for validation should becertified by approved agencies like …IDEMI‟ and …ERTL.2.1.8.3 Brief description about equipment operating function andits location should be mentioned in the report. All rawdata should be handwritten at site during actual validation.2.1.8.4 The details of PLC and HMI hardware are checked as percircuit diagram and type of PLC, HMI, its software Versionno. details, details of the available digital/ analogue inputsand outputs. Installed switchgear details should bementioned i.e. SFU, MCB, relays, contactors, pushbuttons, switch, power supply, Surge protection etc.2.1.8.5 Equipment interlocks, alarms and operation logic shouldbe checked. Details of the PLC Battery conditions shouldbe checked and it‟s life will be verified appropriately.2.1.8.6 All PLC validation reports should be handed over by thevalidation agency to the engineering department forverification within a week after physical verification of thesystem. Engineering, user department and qualityassurance department will verify submitted reports2.1.8.7 Any deviation observed should be highlighted and broughtup to the notice of Engineering/ User/QA dept.2.1.8.8 No changes should be made in the software or hardwareduring the course of validation.2.1.9 Site acceptance test (SAT) and Provisional HandoverCertificate:2.1.9.1 SAT should be carried out in conjugation with thesupplier and may include checks of critical components,controls based on the detail Fat, IQ and OQ have beensuccessfully performed.2.1.9.2 After the equipment goes through the installation andoperational qualification procedure, it should be reviewedat each stage by a team of Engineering, Production,Quality Assurance, Quality Control, Safety and Unit Head.2.1.9.3 In few cases the equipment may have to go through aprocess cycle development and stabilisation phase beforesubject to validation trials.2.1.9.4 If any deviation or non conformance to the acceptancecriteria should be recorded and informed to concernedsupplier. A decision should be taken by user team andsupplier to reject or to proceed for PQ.2.1.9.5 If SAT is found to be satisfactory, equipment should beprovisionally handed over to the concerned departmentfor Performance Qualification.2.1.10 Performance Qualification (PQ):2.1.10.1 During the Performance Qualification the working of thesystem as a whole is checked with respect to out put, quality,quantity and any specific requirements as per designqualification.2.1.10.2 Critical equipment should undergo extensive validationstudies to ensure consistent performance depending onapproved validation protocol.2.1.11 Handover Certificate:After successful Performance Qualification, based on reviewby the team of Engineering, Production, Quality Assurance,Quality Control, Safety and Unit Head. The equipment ishanded over to the concerned department for regular use. 2.2 Equipment Qualification and Requalification protocol consist of thefollowing sections.Covering pageTable of contents.GlossaryPre approvalDesign QualificationCheck list on receiptInstallation QualificationOperation QualificationProvisional Handover CertificatePerformance QualificationHand over Certificate2.3 REQUALIFICATION / PERIODIC QUALIFICATION2.3.1 All Major equipment should be requalified after any majorchange in the equipment or modification.2.3.2 If there are any major changes in critical parameters of equipment(e.g. RPM of blender, speed of agitator etc.) which has directimpact on the quality, then the revalidation of the process should be done.2.3.3 The requalification need not be performed for any minor changesin the equipment, For example, few blades of multimill arereplaced.NOTE: Minor changes should be recorded in the Machine History Card.2.3.4 If any fixed equipment is shifted from one area to another area.Critical parameters should be checked during requalification.Transfer note should be made for the equipment. It should bekept along with the requalification record. For relocation ofportable equipment requalification is not required.2.3.5 During the transfer of equipment from one unit to another unitrequalification as IO, OQ should be conducted based on criticalparameters. A such copy of original qualification should beforwarded for reference.2.3.6 While transferring the equipment to other area / units, reviewshould be done for any specific requirements of conditions2.3.7 For equipment having no changes requalification time periodshould be decided based on performance of annual review of theequipment. The review of the equipment should be recorded inthe Equipment Review Report (Annexure MT95/A1) Therequalification time period should not exceed five years.2.3.8 Schedule for requalification of the major equipment shouldavailable at unit level and should be recorded in schedule forrequalification Annexure MT95/A2.2.3.9 Schedule for PLC revalidation of the major equipment should beavailable at unit level and should be recorded in AnnexureMT95/A3.2.3.10 Any changes in schedule of equipment qualification should becarried out through deviation.Requalification / Periodic Qualification protocol consist of the following sections:Covering pageTable of contents.GlossaryPre approvalOver viewPre requisitePreventive Maintenance verificationMajor breakdown verificationSystem descriptionPhysical verificationCalibration verification of critical componentsCalibration verification of calibration standards usedSafety features verificationControl panel verificationInterlocks/controls verificationPerformance evaluation Documentation verification Post approvalHand over certificate2.4 Protocol Approval:2.4.1 All protocols are approved by Quality Assurance and Unit Headprior to their implementation i.e. after they are compiled by a team of Production, Engineering, Quality Control and Safety.2.4.2 Each protocol should be allotted with a protocol number in theformat specified bellow“QUALI/X” Where,“QUALI” stands for qualification“X” stands for equipment / instrument / balance / area abbreviated code2.4.3 The protocol should also be identified with a Version No., wherethe version no. changes with every change in the Qualification, Requalification and Periodic Qualification of equipment.2.4.4The Qualification, Requalification and Periodic Qualificationprotocol header should consist of the following details as mentioned below Title of the protocol Protocol No. Version No. Department Area Page No.A specimen of the header is given below:2.4.5 Frequency for Periodic QualificationFor Critical Equipment: Once in 3 years of its previousqualification (Initial qualification / requalification)For Non Critical Equipment: Once in 5 years of its previousqualification (Initial qualification / requalification)Note: The period of periodic qualification should be determinedbased on review of history of preventive maintenance, breakdown,calibration data and criticality of process.3.0 ABBREVIATIONS:URS User Requirement SpecificationFDS Functional Design SpecificationDQ Design QualificationFAT Factory Acceptance TestIQ Installation QualificationSAT Site Acceptance TestOQ Operation QualificationPQ Performance QualificationNo. NumberP&ID Piping and Instrumentation DiagramCER Capital Expenditure RequisitionCGMP current Goods Manufacturing PracticesPLC Programmable Logic Controller.MOC Material of Construction材质i.e. That ise.g. For exampleIDEMI Institute for Design of Electrical Measuring InstrumentsERTL Electronics Regional Testing LaboratoryPLC Programmable Logic ControllerHMI Human Machine InterfaceSFU Switch Fuse UnitMCB Miniature Circuit Breaker4.0 REFERENCES:CQA-06 Change Control5.0 ANNEXURES:MT95/A1 Equipment Review Report (MT95/F1)MT95/A2 Schedule for Requalification/Periodic (MT95/F2)QualificationMT95/A3 Schedule for PLC Revalidation /Periodic (MT95/F3)Validation。