This document provides guidance for the interpretation of the principles and guidelines of good manufacturing practice (GMP) for medicinal products as laid down in Directive 2003/94/EC for medicinal products for human use and Directive 91/412/EEC for veterinary use.欧盟GMP指 第5章生产(中英EU GMP...
参考文献 [1] EU.Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use,Annex1: Manufacture of Sterile Medicinal Products[EB/OL].[2022- 08 - 25]. https: / /health. ec. europa. eu /system/files /2022-08 /20220825_gmp-an1_en_0.pdf [2] EU.Guideli...
i. Facility, equipment and process should be appropriately designed, qualified and/or validated and where applicable, subjected to ongoing verification according to the relevant sections of the Good Manufacturing Practices (GMP) guidelines. The use of appropriate technologies (e.g. Restricted Access Bar...
Detailed guidelines in accordance with those principles are published in the Guide to Good Manufacturing Practice which will be used in assessing applications for manufacturing authorisations and as a basis for inspection of manufacturers of medicinal products. 有两项法令阐述了欧盟委员会采用的药品 GMP...
The Rules Governing Medicinal Products in the European Union Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use 欧盟药品管理法规第4卷《人用和兽用药品良好生产规范指南》 Annex 1 附录1 Manufacture of Sterile Medicinal Products ...
1、Module 14Slide 1 of 23WHO - EDMBasic Principles of GMP GMP基本准则Active Pharmaceutical Ingredients 原料药原料药Part Three, 18Module 14Slide 2 of 23WHO - EDMActive Pharmaceutical Ingredients原料药Objectives 目的目的lTo discuss the GMP guidelines for the manufacture of Active Pharmaceutical ...
Annex 1: Guidelines and guidance texts adopted by the Expert Committee on Specifications for Pharmaceutical Preparations附件1:药物制剂规格专家委员会通过的准则和指导文本 Annex 2: WHO good manufacturing practices for sterile pharmaceutical products 附录2:WHO无菌药品生产质量管理规范 Annex 3: IAEA/WHO guide...
1、Guide for Mattel Licensees Mattel 的被许可方行为指南全球制造守则质量安全2010年六月GLOBAL MANUFACTURING PRINCIPLESPRODUCT QUALITY AND SAFETY全球制造守则产品质量安全NEXT STEPS for LICENSEE ACTION许可证持有者行动指示 Mattel is committed to providing fair and safe working conditions and quality and safe ...
Guide for Mattel Licensees Mattel 的被许可方行为指南 全球制造守则 GLOBAL MANUFACTURING PRINCIPLES 质量安全 QUALITY &SAFETY 2010年六月 GLOBAL MANUFACTURING PRINCIPLES PRODUCT QUALITY AND SAFETY 全球制造守则 产品质量安全 NEXT STEPS for LICENSEE ACTION 许可证持有者行动指示 Mattel is committed to providing fai...
1.1.In view of an old publication date,and the recent need for new guidelines arising from inspections carried out forCOVID-19 therapeutics, the World Health Organization (WHO) PrequalificationTeam-Inspection Services (PQT INS) raisedthe urgency for a revision of the WHO Good manufacturing practice...