WHO TRS 1025 附录4 优良色谱规范（中英文下载）

WHOTRS 1025 Annex 4 附录4

Good chromatography practices 优良色谱规范

目录

Good chromatography practices 优良色谱规范       1

1.    Introduction and scope 介绍与范围      2

2.    Glossary 术语    2

3.    Chromatographic systems 色谱系统    4

4.    Qualification, validation, maintenance and calibration确认、验证、维护与校正      5

5.    Access and privileges访问与权限6

6.    Audit trail审计追踪    6

7.    Date and time functions 日期与时间功能     7

8.    Electronic systems电子系统   7

9.    Solvents, buffer solutions and mobile phases 溶剂、缓冲液和流动相  8

10.  Column management 色谱柱管理8

11.  Sample management and sample set 样品管理和样品序列   9

12.  Chromatographic methods (acquisition and processing) 色谱方法（采集和处理）10

13.  Peak integration 峰积分    11

14.  Data management 数据管理   12

References 参考文献      14

Furtherreading 延伸阅读  15

 

1.    Introduction and scope 介绍与范围

1.1  The use of chromatography methods such as high-performance liquid chromatography, also referred to as high-pressure liquid chromatography (HPLC), and gas chromatography (GC) in quality control laboratory analysis has increased significantly in recent years. Observations during inspections have shown that there was a need for a specific good practices (GXP) document.

近年来色谱方法（如高压液相色谱（HPLC）和气相色谱（GC））的使用在QC实验室分析中已有显著增加。检查中所发现的情况显示有必要制订专用的优良规范（GXP）文件。

1.2  HPLC and GC methods are used in, for example, the identification of materials and products, for determination of assay and related substances in materials and products, as well as in validation such as process validation and cleaning validation. Note: Although thin-layer chromatography methods are also used, this approach is not specifically addressed in detail in this document.

HPLC和GC方法被用于，例如，物料和产品鉴别、物料和产品中含量和有关物质检测，以及验证如工艺验证和清洁验证。注：虽然亦会使用薄层色谱方法，但该方法在本文件中不会特别着墨。

1.3  Owing to the criticality of the results obtained through chromatography, it must be ensured that the data acquired meet ALCOA+ principles (i.e. attributable, legible, contemporaneous, original andaccurate, with additional emphases [see Glossary]).

由于通过色谱获得的结果非常关键，所以必须确保所获取的数据符合ALCOA+原则（即可追溯、清晰、同步、原始和准确【参见术语】）。

1.4  This document provides information on GXP to be considered in the analysis of samples when chromatographic methods and  systems are used. The principles should be applied in the analysis of, for example, raw materials, starting materials, intermediates, in-process materials and finished products.

本文件提供了在使用色谱系统进行样品分析时需要考虑的优良规范（GXP）。在分析如原料、起始物料、中间体、中控物料和成品中应使用这些原则。

1.5  The principles contained in this guideline are applicable to general chromatographic analysis used in, for example, assay determination, testing for related substances and impurities, process validation, cleaning validation, cleaning verification and stability testing.

本指南中的原则适用于如含量检测、有关物质和杂质检测、工艺验证、清洁验证、清洁确认和稳定性测试中所用的所有类型色谱分析。

2.    Glossary 术语

The definitions given below apply to the terms used in this guideline that are not defined in existing WHO terms and definitions databases. They may have different meanings in other contexts. Note: For general definitions relating to chromatography, see the relevant pharmacopoeia recognized by the national medicines regulatory authority.

以下定义适用于本指南中所用术语，在现有WHO术语和定义数据库中尚未定义。它们在其它语境中可能有不同含义。注：与色谱有关的通用定义，参见国家药监机构认可的相关药典。

ALCOA.

Acommonly used acronym for “attributable, legible, contemporaneous, original and accurate”.

常用术语，代表“可追溯、清晰、同步、原始和准确”。

ALCOA+.

Acommonly used acronym for “attributable, legible, contemporaneous, original and accurate” that puts additional emphasis on the attributes of being complete, consistent, enduring and available – implicit basic ALCOA principles.

常用术语，代表“可追溯、清晰、同步、原始和准确”，格外强调了完整、一致、持久和可及性—内含的基本ALCOA原则。

audittrail. 审计追踪

Aform of metadata that contains information associated with actions that relate to the creation, modification or deletion of GXP records. An audit trail provides for secure recording of life-cycle details such as creation, additions, deletions or alterations of information in a record, either paper orelectronic, without obscuring or overwriting the original record. An audittrail facilitates reconstruction of the history of such events relating to the record, regardless of its medium, including the “who, what, when and why” of the action.

含有创建、修改或删除GXP记录活动相关信息的元数据表格。一份审计追踪会提供生命周期详细信息的安全记录，如创建、增加、删除或修改一份纸质或电子记录中的信息，而不会使原始记录不能识别或覆盖改写原始记录。审计追踪有利于重建此类与记录有关的活动的历史，包括活动的人物、内容和原因信息，而不受介质形式的影响。

back-up.备份

Acopy of one or more electronic files created as an alternative in case the original data or system are lost or become unusable (for example, in the event of a system crash or corruption of a disk). It is important to note that back-up differs from archival, in that back-up copies of electronic records are typically only temporarily stored for the purposes of disaster recovery and maybe periodically overwritten. Such temporary back-up copies should not be relied upon as an archival mechanism.

备份指创建一份或多份电子文件，在原始数据或系统丢失或不可使用时（如系统崩溃或磁盘损坏）作为替代用途。注意备份与归档是不一样的，电子记录备份一般只是临时存贮用于灾难恢复，可能会定期覆盖。不应依赖此种临时备份件作为归档用途。

calibration.校正

Theset of operations that establish, under specified conditions, the relationship between values indicated by an instrument or system for measuring (especially weighing), recording and controlling, or the values represented by a material measure, and the corresponding known values of a reference standard. Limits for acceptance of the results of measuring should be established.

在指定条件下建立仪器或系统测量指示值（尤其是称重值）、记录和控制，或物料测量代表值，与对应的一个标准物质已知值关系的一系列操作。应建立测量结果的可接受限度。

data.数据

All original records and true copies of original records, including source data and metadata and all subsequent transformations and reports of these data, that are generated or recorded at the time of the good manufacturing practices (GMP) activity and allow full and complete reconstruction and evaluation of the GMP activity. Data should be accurately recorded by permanent means at the time ofthe activity. Data may be contained in paper records (such as worksheets and logbooks), electronic records and audit trails, photographs, microfilm or microfiche, audio- or video-files, or any other media whereby information related to GMP activities is recorded.

所有原始记录和原始记录的真实副本，包括源数据和元数据以及这些数据的所有后续转移及报告。这些数据是在GMP活动时生成或记录的，可全面完整重构及评估该GMP活动。数据应在活动发生时采用永久方法准确记录。数据可保存在纸质记录上（例如工作记录和日志）、电子记录上和审计追踪上、图片上、微缩胶卷上、影音文件或任何其它记录与GMP活动有关信息的媒介上。

data integrity. 数据完整性

The degree to which data are complete, consistent, accurate, trustworthy andreliable and to which these characteristics of the data are maintained throughout the data life-cycle. The data should be collected and maintained ina secure manner, such that they are attributable, legible, contemporaneously recorded, original or a true copy and accurate. Assuring data integrity requires appropriate quality and risk management systems, including adherence to sound scientific principles and good documentation practices.

数据的完整、一致、准确、可信任和可靠程度，以及数据的这些特性在其生命周期中得到保持的程度。数据应以安全的方式采集和保存，使得其可追溯、清晰、同步记录、原始或成为真实副本以及准确。确保数据完整性需要有适当的质量和风险管理体系，包括严守科学合理原则和优良文件记录规范。

metadata.元数据

Data about data that provide the contextual information required to understand those data. Metadata necessary  to  evaluate the  meaning  of data should be securely linked to the data and subject to adequate review. Examples of metadata include the time/date stamp of an activity, the operator identification (ID) of the person who performed an activity, the instrument ID used, processing parameters, sequence files, audit trails and other data required to understand data and reconstruct activities.

元数据是提供理解数据所需环境信息的数据。其中包括结构性和描述性元数据。此类数据描述结构、数据元素、相互关系和数据的其它特性。他们亦可让数据追溯至个人。评估数据含义所需的元数据应与数据安全链接，并进行充分审核。例如，在称重过程中，如果没有元数据，如单位mg等，数字8是无意义的。元数据的其它例子包括一个活动的时间/日期戳，执行活动的操作员身份（ID）、所用仪器ID、处理参数、序列文件、审计追踪和理解数据和重构活动所需的其它数据。

qualification.确认

Documented evidence that premises, systems or equipment are able to achieve the predetermined specifications, are properly installed, and/or work correctly,and lead to the expected results.

证明设施、系统或设备能够达到预定标准、适当安装，和/或正确运转并获得预期结果的文件化证据。

sample set. 样品序列

The combination of samples, standards and blanks prepared for analysis, which includes the specified sequence to be injected or analysed.

为分析所制备的样品、对照品和空白的组合，其中包括要进针或分析的指定序列。

sourcedata. 源数据

Original data obtained as the first-capture of information, whether recorded on paper or electronically.

在信息首次捕获中获取的纸质或电子原始数据。

validation.验证

The action of proving and documenting that any process, procedure or method actually and consistently leads to the expected results.

证明和记录所有工艺、程序或方法实际持续获得预期结果的活动。

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