原料药GMP指南(中英文对照).pdf,2022年-2023年(可修改编辑) Q7a (中英文对照) FDA原料药GMP指南 Table of Contents 目录 1. INTRODUCTION 1. 简介 1.1 Objective 1.1目的 1.2 Regulatory Applicability 1.2法规的适用性 1.3 Scope 1.3范围 2. QUALITY MANAGEMENT 2.质量
procedure to prevent any person who has an apparent illness from entering areas in which they may adversely affect the quality of the product or affect their own health 12 Section 10 22 Is smoking eating drinking and chewing prohibited in production storage and laboratory areas 9 REF WHO 32 ...
Further reading 延伸阅读 1Introduction andscope 介绍及范围 intendsto provideinformationabout water. 本文件包括制药用水(WPU)的生产、储存和分配。本文 件提供不同制药用水标准、水系统质量管理的GMP指南、水 处理(生产)系统、制药用水储存和分配系统、确认和验证、 以及取样、测试和水的日常监测相关的信息。 and...
附录2 WHO药品GMP指南_中英文_.pdf,Annex 2 WHO good manufacturing practices for pharmaceutical products: main principles 附录2 WHO药品GMP:主要原则 Introduction引言 General considerations总则 Glossary术语 Quality management in the medicines industry: philo
欧盟GMP检查SOP.pdf,Standard operating procedure Title: Co-ordination of GMP/GDP inspections Status: PUBLIC Document no.: SOP/INSP/2048 Lead author Approver Effective date: 27-SEP-12 Name: Esther Martinez Name: David Cockburn Review date: 27-SEP-15 Signat
法规管理者是谁EuropeanMedicinesAgency(EMEA)欧洲药物管理局(EMEA)decentralisedbodyoftheEuropeanUnionwithheadquartersinLondon.欧盟旳分散机构,其总部在伦敦TheEMEAisresponsibleforthescientificevaluationofapplicationsforEuropeanmarketingauthorisationformedicinalproducts(centralisedprocedure).Underthecentralisedprocedure,companiessubmit...
Where the CCS indicates that the risk of contamination is high, separate change Current Annex 1-2008 should be sterilised and passed into the area through double-ended sterilisers sealed into the wall, or by a procedure which achieves the same objective of not introducing contamination. Non- ...
A procedure should be established for retaining all appropriate documents (., development history reports, scale-up reports, technical transfer reports, process validation reports, training records, production records, control records, and distribution records). The 应当制订一个保存所有适用文件(如开发历程...
procedure has been established to ensure that no single container of starting material has been incorrectly labelled. 3. This validation should take account of at least the following aspects: — the nature and status of the manufacturer and of the supplier and their understanding of the GMP ...
WHO临床试验用药品GMP 草案 中英文版.pdf,Working document QAS/20.863 Good Manufacturing Practices for Investigational Product DRAFT WORKING DOCUMENT FOR COMMENTS: Goodmanufacturing practices for investigationalproducts Please send your comments to Dr Sabin