仪器确认 附件4 红外确认 中英文.doc

欧洲药品质量管理局—仪器确认指南(中英对照)-4

OMCL Network of the Council of Europe

QUALITY ASSURANCE DOCUMENT

质量保证文件

PA/PH/OMCL (07) 12 DEF CORR QUALIFICATION OF EQUIPMENT

仪器确认

ANNEX 4: QUALIFICATION OF IR SPECTROPHOTOMETERS

附件4 红外分光光度计的确认

欧洲药品质量管理局—仪器确认指南(中英对照)-4

ANNEX 4 OF THE OMCL NETWORK GUIDELINE

“QUALIFICATION OF EQUIPMENT” OMCL网络指南“仪器确认”附件4

QUALIFICATION OF IR SPECTROPHOTOMETERS

红外分光光度计的确认

Introduction 介绍

The present document is the fourth Annex of the core document “Qualification of Equipment”, and it should be used in combination with it when planning, performing and documenting the IR spectrophotometer qualification process.

本文件为“仪器确认”核心文件的第四个附件，在对红外分光光度计确认过程进行计划、实施和记录时，应结合该核心文件一起使用。

The core document contains the Introduction and general forms for Level I and II of qualification, which are common to all type of instruments.

核心文件包括了第一级和第二级确认的介绍和通用表格，该表格通用于各类型仪器。 For FTIR spectrometers, an example has been added to give instrument-specific proposals that may be used in combination with the general requirements presented in the core document “Qualification of Equipment”, when drawing up a Level I checklist.

对于傅立叶红外变换光度计，在本指南中给出一个仪器专用的方案，在起草第一级检查清单时，与“仪器确认”核心文件中的第一级通用表格一起使用。

The present annex contains instrument-related recommendations on parameters to be checked at Level III and IV of qualification and the corresponding typical acceptance limits, as well as practical examples on the methodology that can be used to carry out these checks.

附件中包括了与仪器相关，在第三级和第四级确认中需要检查的参数，以及其相应的典型可接受限度，和用于实施这些检查的实用方法举例。

欧洲药品质量管理局—仪器确认指南(中英对照)-4

TABLE I 表一

Level I. Selection of instruments and suppliers 第一级 仪器和供应商选择

Example of check-list (non-exhaustive) 检查清单举例（未尽列举） Manufacturer: 生产商

Provider/Distributor: 分销商/供货商

Name of instrument and type: 仪器名称和型号

欧洲药品质量管理局—仪器确认指南(中英对照)-4

Notes: 注

— This check-list, containing examples of technical attributes that can be taken into account in the

selection of an instrument and supplier, can be used in combination with the general check-list presented in Level I in the core document “Qualification of Equipment”. — 本检查清单包括了技术特性举例，在选择仪器和生产商时可以进行考虑，可以与核心文件“仪

器确认”中第一级通用检查清单结合使用。 — For Table II (Level II of Equipment Qualification: Installation and release for use) please refer to the

core document. — 表二（第二级仪器确认 安装和使用放行）参见核心文件

欧洲药品质量管理局—仪器确认指南(中英对照)-4

TABLE III 表三

Level III. Periodic and motivated instrument checks 第三级 周期性主动仪器检查

Examples of requirements for IR spectrophotometers 红外分光光度仪的要求举例

TABLE IV 表四

Level IV. In-use instrument checks 第四级 在用仪器检查

Examples of requirements for IR spectrophotometers 红外分光光度计要求举例

欧洲药品质量管理局—仪器确认指南(中英对照)-4

ANNEX I 附件1

Level III. Periodic and motivated instrument checks 第三级 周期性主动仪器检查

This Annex contains practical examples of tests and their associated tolerance limits for several parameters related to the performance of an IR spectrophotometer.

本附件包括了红外分光光度计性能相关的几个参数的检查实例及其相关的允许限度

These examples can be considered by the OMCLs as possible approaches to perform the Level III of the equipment qualification process: “Periodic and motivated instrument checks”.

这些举例可以认为是OMCL在实施第三级检查“周期性主动仪器检查”时可能方法。 Note: If available and judged appropriate, the use of the automatic internal calibration function of the instrument is encouraged. Please refer to the manufacturer instructions.

注：如可能，且判断为适用，鼓励采用仪器内置校正功能。参见供应商指导手册。

1. WAVE-NUMBER SCALE 波数刻度 Method and Limits:方法和限度

The wave-number scale may be verified by recording the spectrum of a polystyrene film, which has transmission minima (absorption maxima) at the wave numbers (in cm-1) shown in the table below: 确认波数刻度时，记录聚苯乙烯薄膜的图谱，该图谱最小透过率（最大吸收）波数值（cm-1）列于下表。

Limits: 限度

Energy ratio test specifications vary for each spectrometer configuration. Refer to the manufacturer’s specification.

能量比测试标准根据各仪器参数不同，参见生产商标准。

欧洲药品质量管理局—仪器确认指南(中英对照)-4

3. SIGNAL/NOISE RATIO 信噪比 Method: 方法

Record the maximum noise level for each of the following regions: 记录以下波数区域最大噪声水平 Peak-to-peak noise between: 噪声波数区域

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