第壹部分 歐盟藥品管理概述
第二部分 歐盟GMP基本要求
引言
基本要求Ⅰ：人用藥品及獸藥制劑生產質量管理規範
基本要求Ⅱ：原料藥生產質量管理規範
第三部分 歐盟GMP附錄
歐盟GMP附錄1 無菌藥品的生產
歐盟GMP附錄2 人用生物制品的生產
歐盟GMP附錄3 放射性藥品生產’
歐盟GMP附錄4 獸用非免疫藥品的生產
歐盟GMP附錄5 免疫類獸藥制品的生產
歐盟GMP附錄6 醫用氣體生產
歐盟GMP附錄7 草藥制劑的生產
歐盟GMP附錄8 原輔包裝材料的取樣
歐盟GMP附錄9 液劑、霜劑和油膏的生產
歐盟GMP附錄10 定量吸人式氣霧劑的生產
歐盟GMP附錄11 計算機系統
歐盟GMP附錄12 藥品生產中電離輻射的應用
歐盟GMP附錄13 臨床試驗用藥的生產
歐盟GMP附錄14 人血液或血漿制品的生產
歐盟GMP附錄15 確認和驗證
歐盟GMP附錄16 藥品放行責任人簽發證書和放行批產品
歐盟GMP附錄17 參數放行
歐盟GMP附錄19 對照樣品和留樣
歐盟GMP附錄20 質量風險管理
歐盟GMP術語
第四部分 歐盟GMP原文
Introduction
Part Ⅰ-Chapter I Quatity management
Part Ⅱ-Basci Requirements for Active Substances used as Starting Materials
Annex 1 Manufacture of Sterile Medicinal Products
Annex 2 Manufacture of Biological Medicinal Products for Human Use
Annex 3 Manufacture of Radio Phannaceuticals
Annex 4 Manufacture of Veterinary Medicinal Products other than Immunological Veterinary Medicinal Products
Annex 5 Manufacture of Immunological Veterinary Medicinal Products
Annex 6 Manufacture of Medicinal Gases
Annex 7 Manufacture of Herbal Medicinal Products
Annex 8 Sampling of Starting and Packaging Materials
Annex 9 Manufacture of Liquids, Creams and Ointments
Annex 10 Manufacture of Pressurised Metered Dose Aerosol Preparations for Inhalation
Annex 11 Computerised Systems
Annex 12 Use of Ionising Radiation in the Manufacture of Medicinal Products
Annex 13 Manufacture of Investigational Medicinal Products
Annex 14 Manufacture of Products derived from Human Blood or Human Plasma
Annex 15 Qualification and validation (July 2001)
Annex 16 Certification by a Qualified Person and Batch Release (July 2001)
Annex 17 Parametric Release (July 2001)
Annex 19 Reference and Retention Samples (December 2005)
Annex 20 Quality Risk Management