CGMP文件_工作对照品杂质对照品的接收处理保管标准程序SOP.pdf

文件编码Doc. No.: 标准操作程 颁发日期： 生效日期： 序 Issue Date: Effective Date: Standard 复审日期： Operating 替代： Supersedes: Review Date: Procedure 页码：第1 页共5 页Page No.: 1 of 5 标题：工作对照品/对照品/杂质对照品的接收、处理和保管标准程序 TITLE: RECEIPT, HANDLING AND MAINTENANCE OF WORKING/REFERENCE AND IMPURITY STANDARD 1.0 目的 Purpose: 描述工作对照品/对照品/杂质对照品的接收、处理和保管的标准程序 To lay down a procedure for receipt, handling and maintenance of working standard/ reference standard and impurities. 2.0 范围 Scope: 本程序适用于工作对照品/对照品/杂质对照品的接收、处理和保管。这些对照品来自研 发部门和外部原料药生产商。 This procedure is applicable for receipt, handling and maintenance of working standard/reference standard and impurities received from RD External API vendor. 3.0 定义 Definitions: 无Nil 4.0 责任 Responsibility: 所有的QC 人员有责任在他们的岗位上遵循此标准操作程序的操作。 All QC personal are responsible for following this SOP as per their respective roles. 5.0 程序 Procedure 5.1 接收Receipt: 5.1.1 在接收的时候，检查是否有检验报告单（COA ）和支持性数据。若没有， 则向厂家索 。检查容器是否完好无损，对比COA 和标签的内容。 At the time of receipt, check the availability of Certificate of Analysis (COA) and supporting data. If not, then ask the source to provide them. Check the intactness of containers and compare the contents of COA and label. 5.1.2 如果发现不符合之处，跟生产商联系来更正它。 If any discrepancy is observed, then contact supplier to correct them. 5.1.3 按照附录-I 的要求记录每个工作对照品/对照品/杂质对照品的接收细节。 Record the receipt details of each working standard/reference standard and impurities as per Annexure-I. 5.1.4 接收的序号应被视为工作对照品/对照品/杂质对照品的内部编码。