大仁中草藥商機-中藥GMP製造流程及管理法規研究

陳瑞龍
大仁技術學
藥品優良製造規範和管理藥品之法律對保護消費者，免於遇受藥物所引起之危險，但目前國內對於中藥，不論是GMP或管理規章，均嫌不足。本研究將嘗試檢討這些問題，並提出建議書，供政府制訂乃至於修改時之參考，具體而言，研究對象如下所示：1)中藥優良藥品製造規範2)中藥製程確效3)中藥藥品查驗登流程及文件4)中藥上市後管理Both 93年度 編號:CCMP93-RD-025
關鍵字：中藥GMP、製造流程、管理法規、確效

A Tajen Project on Maket Opportunity of Chinese Herbs-Studies on the GMP issues and regulatory manipulations

Rhei-Long Chen
Tajen Institute of Technology
GMP and some laws managing drug product are important for protecting persons from the danger caused by drugs. But they are not complete for herbal drugs. In this study, we attend to coordinate the opinions of herbal medicine producers and scholars, then submit proposal, used to estiablish laws, to government. Concretely the objects of this study are shown as follows:1) Good manufacturing practices for herbal medicines 2) Process validation for producing herbal medicines3) Flow and documents of registration of herbal medicines4) Mangement of marketing herbal medicines
關鍵字：Chinese medicine GMP,Pharmaceutical Technology,Manufacturing process management,Process validation