《对照品管理SOP》.docVIP

起草/修订人： Author 日期： Date 部门主管审查： Dept. Head Approval 日期： Date QA批准： Approved by QA 日期： Date 分 发：Distribution: QA, QC, RD 目的： 描述化验室对照品的接收、确认、贮存、库存、分发、使用的规程。 PURPOSE: This procedure describes a process used by Lab operation for the receipt, qualification, storage, inventory, distribution and use of analytical reference standard 范围： 适用于化验室内所用的对照品，包括基准对照品、第二对照品。 SCOPE: This procedure is applicable to analytical reference standards used in QC lab, includes the Primary Reference Standards and the Secondary Reference Standards 参考文件： REFERENCE AND ATTACHMENT: SOP/题目 SOP/TITLE 记录/附件/题目 FORMS/ATTACHMENTS/TITLE 3-0002 OOS调查 附件1： 对照品标签样例 Result Attachment 1: Reference Standard Label (Example) F-03-010 对照品登记台帐 Reference Standard F-03-011 对照品接收记录 Reference Standard F-03-012 对照品使用记录 se Record of Reference Standard 定 义： DEFINITIONS: 基准对照品 以广泛分析表明具有可信的、高纯度的物质。这类标准品可以：1）来源于法定机构；2）独立合成；3）来自于高纯度的现有生产物料；4）用进一步精制现有生产物料的方法来制备。 Reference Standard, Primary A substance that has been shown by an extensive set of analytical tests to be authentic material that should be of high purity. This standard could be: (1) obtained from an officially recognized source, (2) prepared by independent synthesis, (3) obtained from existing production material of high purity, or (4) prepared by further purification of existing production material. 第二对照品 与基准对照品比较显示有规定的质量和纯度，并用作日常检验分析的参考标准品。 Reference Standard, Secondary A substance of established quality and purity, as shown by comparison to a primary reference standard, used as a reference standard for routine laboratory analysis. 规 程： PROCEDURE: 责 任 人 操 作 RESPONSIBILITY ACTION 1. 对照品接收 RECEIPT QC主管 1.1 QC主管指定专人负责对照品的管理；对照品管理员负责对照品的接收、贮存以及发放等的管理。 QC upervisor QC Supervisor designee is responsible for the management of all reference standards, such as the receipt, storage and distribution of reference standard. 对照品管理员 1.