CGMP文件-药典对照品的接收、储存、使用和保管程序SOPVIP专享

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 STANDARD1.0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 PharmacopoeiaBP: 英国药典 British PharmacopoeiaEDQM：欧洲药品质量理事会 European Directorate for the Quality of MedicinesNICPBP：中国药品生物制品检定所National Institute for the Control of Pharmaceutical and Biological Products4.0责任 Responsibility:QC 检验员/组长/经理助理/经理QC analysts/Group Leader/ Assistant Manager/ Manager5.0程序 Procedure :5.1 接收和储存 Receipt and storage5.1.1 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.制定人Prepared by审核人Reviewed by批准人Approved by签名/日期Sign / Date名字Name 职务Designation 文件编码 Doc. No.: Page 2 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 STANDARD5.1.2 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: www.usp.org-EP 对照品 For EPCRS...