頁籤選單縮合
題名 | 各國品質管理人員(QP)制度之探討=Survey on the System of Qualified Person in Other Countries |
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作者姓名(中文) | 謝綺雯; 黃琴喨; 李明鑫; 陳惠芳; | 書刊名 | 食品藥物研究年報 |
卷期 | 5 2014.12[民103.12] |
頁次 | 頁387-393 |
分類號 | 418.41 |
關鍵詞 | 優良製造規範; 品質管理人員; 監製藥師; Good manufacturing practice; Qualified person; Pharmacist; |
語文 | 中文(Chinese) |
中文摘要 | 藥品實施優良製造規範(Good Manufacturing Practice, GMP)是確保製藥品質的關 鍵措施,為保障民眾用藥安全,我國自71年開始要求藥品製造必須符合GMP,並隨 著品質觀念的革新,不斷更新我國西藥GMP的規範。101年度發生GMP藥廠將藥品 委託非GMP藥廠(食品廠)執行分裝案,各界並對製藥工廠所聘用之監製藥師是否落實 監督管理職責引發高度之關注。食品藥物管理署為杜絕類似情形再次發生,藉由蒐 集國際間行之多年的「品質管理人員(Qualified person,以下簡稱QP)」制度,瞭解各 國對藥品製造與品質把關機制,此外,問卷調查結果發現國內GMP製藥工廠所聘用 之監製藥師缺乏實際職權執行監督管理職務,顯示監製藥師之職責及訓練等之管理 應有再加強之必要。現階段致力於向廠商宣導落實監製藥師監督藥品製造與品質管 理,並配合推動QP制度等措施,強化國內監製藥師的監督管理的功能,以保障民眾 用藥安全。 |
英文摘要 | Good Manufacturing Practices (GMP) is the key to assuring quality of pharmaceutical products. To safeguard public use of pharmaceutical products, mandatory GMP implementation and compliance by all manufacturers was announced in 1982 by the Department of Health, Taiwan, and is kept up-to-date with global new quality concepts and development. In 2012 it happened that primary packaging operation of some pharmaceutical products were contracted to non-GMP manufacturers, and this has lead to public concern on the adequacy of pharmacists employed by the pharmaceutical manufacturers in executing their supervisory roles. To preclude similar happenings, Taiwan FDA gathered information on the international practice of Qualified Person (QP) to understand how manufacturing and quality control of pharmaceutical products were regulated internationally. In addition, results of the survey indicated that pharmacists employed by the domestic GMP manufacturers are not fully authorized to execute their supervisory duties. This shows training on full authorization and awareness of pharmacists supervising responsibilities should be reinforced. At present, key efforts are focused on addressing all manufacturers the importance and responsibilities of the pharmacists in supervising the manufacturing and quality assurance of the products, at the same time, facilitate the implementation of a QP system, in order to solidify the roles and supervisory responsibilities of the pharmacists, with the goal to safeguard public use of medicinal products. |
本系統之摘要資訊系依該期刊論文摘要之資訊為主。