GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS 國際藥品稽查合作組織國際藥品稽查合作組織(PIC/S) 藥品優良製造準則藥品優良製造準則 ★本中文版係為★本中文版係為 PIC/S GMP 規範(版本編號:期:期:2003 年年 9 月月 1 日)之譯本日)之譯本 規範(版本編號:PE009-1,修訂日,修訂日*備註...
gmp附录pics指南guide药品 INTRODUCTION General概述 Inordertofurtherfacilitatetheremovalofbarrierstotradeinmedicinalproducts,topromoteuniformityin licensingdecisionsandtoensurethemaintainingofhighstandardsofqualityassuranceinthedevelopment, manufactureandcontrolofmedicinalproducts,thefollowingGuidetoGoodManufacturingPracticefor ...
内容提示: GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS 國際藥品稽查合作組織國際藥品稽查合作組織(PIC/S) 藥品優良製造準則藥品優良製造準則 ★本中文版係為★本中文版係為 PIC/S GMP 規範(版本編號:期:期:2003 年年 9 月月 1 日)之譯本日)之譯本 規範(版本編號:PE009-1,修訂日,...
x 本帖最后由 halfmoon 于 2023-6-25 15:06 编辑 最新PIC/SGMP指南 （２０２３）Guide to Good ...
PICS GMP中文版(第一部分)西藥藥品優良製造規範 （第一部）PIC/S：Guide to Good Manufacturing Practice for Medicinal Products （Part I）PE009-13 (1 January 2017)© PIC/S January 2017
Hence, this guide is not intended to impose additional regulatory burden upon regulated entities, rather it is intended to provide guidance on the interpretation of existing GMP/GDP requirements relating to current industry data management practices. 良好的数据管理一直被认为是GMP/GDP不可或缺的一...
PICS GMP中英文对照.doc,GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS 国际药品审计合作组织(PIC/S) 药品生产质量管理规范指引 主办单位:卫生署药政处、药物食品检验局 协办单位:经济部工业局 承办单位:社团法人台湾药物质量协会 日期:2003年 CHAPTER
基本的gmp要求为:i. all manufacturing processes are clearly defined, systematically reviewed in the light of experience and shown to be capable of consistently manufacturing medicinal products of the required quality and complying with their specifica 18、tions:i. 所有制造过程均已加以清楚规定,按照经验...
They are described here in order to 译 emphasise their relationships and their fundamental importance to the production and control of medicinal products. 质量管理、良好制造规范(GMP)和质量风险管理三者是相互关联的。描述它们是为了 强调它们的关系,以及它们对药品生产和控制的重要性。 翻 PHARMACEUTICAL ...
current PIC/S GMP Guide.2.1.2 The purpose of this document is to provide guidance for GMP inspectors in reviewing the issues covered to use for training purposes and in preparation for inspections.2.1 本文件的目的 2.1.1 这些建议性文件的主题涉及的是那些审计人员和制药企业都认为需要对现行PIC...