WHO TR 1025 Annex 4 WHO TR1025 附件 4 Good chromatography practices 良好色谱规范 翻译:流浪的沙子 校对:Owen GMP 办公室翻译组 1. Introduction and scope 介绍及范围 2. Glossary 术语 3. Chromatographic systems 色谱系统 4. Qualification, validation, maintenance and calibration 确认,验证,维护和校准 5. Access and privileges 访问及权限 6. Audit trail 审计追踪 7. Date and time functions 日期和时间功能 8. Electronic systems 电子系统 9. Solvents, buffer solutions and mobile phases 溶剂、缓冲液和流动相 10. Column management 色谱柱管理 11. Sample management and sample set 样品管理和样品集 WHO TR1025 附件 4 良好色谱规 1 / 22 GMP 办公室翻译组 12. Chromatographic methods (acquisition and processing) 色谱方法(采集和处理) 13. Peak integration 峰积分 14. Data management 数据管理 References 参考资料 Further reading 更多阅读 WHO TR1025 附件 4 良好色谱规 2 / 22 GMP 办公室翻译组 1. Introduction and scope 1.介绍和范围 1.1 The use of chromatography methods such as highperformance 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(如高效液相色谱,也称高压液相色谱(HPLC),和气 相色谱(GC))的使用在 QC 实验室分析中已有显著增加。从检查过程的 观察项表明,需要一份特定的良好规范(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 thinlayer 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。注意:虽然薄层色谱法也 被使用,但是这种方法在本文中没有详细说明。 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 and accurate, with additional emphases [see Glossary]). 由于色谱分析结果的重要性,生产商应确保所获取的数据的准确性和可靠 性。结果应符合 ALCOA+原则(即可追溯、清晰、同步、原始和准确,详 见术语)。 1.5 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方法和系统进行样品分析时应考虑的 GXP 信息。 在原料、起始物料、中间体、中控物料和成品的分析中应使用这些原则。 1.6 general The principles contained in this guideline are applicable to chromatographic analysis used in, for example, assay WHO TR1025 附件 4 良好色谱规 3 / 22 GMP 办公室翻译组 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 2.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. A commonly 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+. A commonly 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”,以及在其上增加 ALCOA 基本原则的更多属性,即完整、一致、持久和可及性。 audit trail. 审计追踪 A form 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 or electronic, without obscuring or overwriting the original record. An audit trail facilitates reconstruction of the history of such events relating to WHO TR1025 附件 4 良好色谱规 4 / 22 GMP 办公室翻译组 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 A copy of one or more electronic files created as a

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