CGMP文件_药典对照品的接收、储存、使用和保管程序SOP.docVIP

标准操作程序 Standard Operating Procedure 文件编码Doc. No.: 颁发日期： Issue Date: 生效日期： Effective Date: 替代： Supersedes: 复审日期 Review Date: 页码：第1页共4页Page No.: 1 of 4 标题： 药典对照品的接收、储存、使用和保管程序 TITLE: PROCEDURE FOR RECEIPT, STORAGE, USE AND MAINTENANCE OF PHARMACOPOIEAL REFERENCE STANDARD 1.0 目的　Purpose : 规定药典对照品的接收、储存、使用和保管程序。 To lay down a procedure for receipt, storage, use and maintenance of pharmacopoieal reference standard. 2.0 范围　Scope : 本SOP适用于QC实验室从药典部门（USP/BP/EDQM/NICPBP）接收的所有对照品。 This SOP applies to all reference standards used in the QC laboratory, which are received from pharmacopoieal agencies USP/BP/EDQM/NICPBP . 3.0 定义　Definitions : USP： 美国药典 United States Pharmacopoeia BP: 英国药典British Pharmacopoeia EDQM： 欧洲药品质量理事会European Directorate for the Quality of Medicines NICPBP： 中国药品生物制品检定所 National Institute for the Control of Pharmaceutical and Biological Products 4.0 责任　Responsibility: QC 检验员/组长/经理助理/经理 QC analysts/Group Leader/ Assistant Manager/ Manager 5.0 程序　Procedure : 5.1接收和储存Receipt and storage 5.1.1 对照品应从药典部门或其授权代理机构购买。 Reference standards should be procured from pharmacopoieal agency or by their authorized agent. 5.1.2 接收对照品时应从下列网站下载最新的对照品目录并检查是否现行批号。 On receipt of reference standards, check whether the lot is current or not from the latest catalogs downloaded from following websites: USP对照品For USPRS: EP对照品For EPCRS: BP对照品For BPCRS: www.bpclab.co.uk Ch.P对照品 For Ch.PRS: / 5.1.3 检查瓶子包装应完好无损，标签正确无误。 The vial should be checked for intactness and correctness of label. 5.1.4 接收情况应在附件-I中所示的《对照品接收记录》中记录 The receipt should be recorded in the ‘Reference Standards Receipt Record’ as per Annexure-I. 5.1.5 对照品序号应作为内部编码并用以使用情况追溯。 The serial number should be treated as In-house identification number and should be used for reference purpose. 5.1.6任何相关资料、包装的完好无损、现行批号状况和有效期（如果有）应记录在备注栏中。 Receipt of any literature, intactness of vial, current lot status and expiry date If applicable should be recorded in the remark column. 5.1.7 所有对照品应按药典机构在标签上或个别文件中描述的储存条件进行储存