药品实验室分析仪器验证规范的探讨

分析仪器验证是药品实验室质量管理的重点，是符合制药业良好操作规范的关键部分，也是国内外制药行业在实施过程中的难点。本文结合国际上相关规范和标准，对药品实验室分析仪器验证要求和过程进行探讨。仪器验证是一个整体、周期性的过程，是由不同阶段的活动组成，需要仪器制造商、供应商和使用者三方共同参与。文章将仪器验证分为三个阶段进行阐述，从仪器和制造商、供应商的选择到仪器的安装、测试和批准使用，包括仪器的定期核查、校准和维护，分别介绍每个阶段活动的实施要点和记录要求，为我国药品实验室分析仪器验证提供参考，促进实验室质量管理标准与国际接轨。

Discussion on specification for analytical instrument qualification in phar-maceutical laboratory

Analytical instrument qualification is the focus of quality management in the pharmaceutical laboratory, is key part of the good manufacturing practice （GMP） standard for pharmaceutical industry, but also the difficulty in the actual implementation process for domestic and foreign pharmaceutical industries. Based on international guides and standards, the aim of this paper is to discuss analytical instruments qualification and management for pharmaceutical laboratory. The required instrument qualification is a whole cyclical process which is composed by the activities of the different stages. Instrument manufactures, suppliers and users of the three parties should participate in this whole qual-ification process. This paper is to describe the activities of instrument qualification in three stages, from the instrument manufacturer and supplier selection to instrument installation, performance testing and approval of the instrument use, including instrument periodic verification, calibration, maintenance and daily check. This paper is to discuss the imple-mentation points of the qualification activities and records requirements at each stage. This paper approaches reference for Chinese pharmaceutical laboratory on qualification of analytical instruments, to promote laboratory quality manage-ment standards and in line with international standards.