2011-01-012024-05-15https://scholars.lib.ntu.edu.tw/handle/123456789/663606摘要：本計畫將蒐集cGMP相關資料，擬定確效作業手冊，經專家會議定稿，並與主管機關及相關業者討論共同規劃未來動物用藥廠實施cGMP制度之藍圖，提供國內推動動物用藥品cGMP之參考。本年度之工作內容如下： (1) 收集動物用藥廠實施cGMP文件。 (2) 研擬確校作業指導手冊，經專家討論會定稿。 (3) 舉辦教育訓練課程及業者溝通說明會。 (4) 提出國內推動動物用藥品cGMP之之時程及相關作業辦法草案。<br> Abstract: To upgrade the quality of veterinary medicinal products and the competitiveness of this industry, This project aims to collect cGMP regulatory information, propose validation guidance which will be approved by expert meetings, discuss with representatives from the authorities and veterinary drug manufacturers to develop a draft proposal for implementing cGMP regulation for veterinary drugs. The specific aims of this project include: (1) Collecting information related to the cGMP regulation of veterinary medicinal products. (2) Propose validation guidance which will be approved by expert meetings. (3) Offering cGMP-related training courses and public meetings to communicate with the industry for the implementation of veterinary drug cGMP. (4) Finalize a draft proposal and a schedule for implementing veterinary drug cGMP.動物用藥品製藥確效veterinary drugmanufacturevalidation