- 期刊
新興生醫產品之品質要求：GTP與GMP之比較
Quality Requirements for the Advanced Therapy Medicinal Products: GTP and GMP
摘要
近年來細胞醫療的科技發展進步神速，對一些傳統醫療方式無法克服的疾病帶來了希望。然而以醫療產品風險管理的角度來看，新興生醫產品沒有長期的使用經驗，所以難以評估各種潛在風險，只能在產品製程方面從來源、製備過程以及放行標準等去做規範，以期使其應用風險降到最低。本文旨在介紹細胞醫療產品領域目前的法規要求及其精髓，從目前細胞產品的分類說明，到目前國際管理規範中的GTP（人體細胞組織優良操作規範）以及GMP（西藥藥品優良製造作業規範）的要求，以期能使從事此領域的各方，務必以病人的福祉出發，製造真正具有效性及安全性細胞醫療產品。
並列摘要
In recent years, rapid progress has been made in the field of cell therapy, bringing a glimmer of hope to those with diseases that regular medicinal products cannot overcome. However, from the risk management perspective regarding the use of medicinal products, there are no long-term experiences with the use of cell therapy products, such that all kinds of potential risks remain unknown. As such, risks can only be minimized by standardizing production in terms of aspects such as source materials, production processes, and release specifications. This article aims to introduce the current regulations and fundamentals of cell therapy, from the classification of cell products to the current international management standards for Good Tissue Practices (GTP) and Good Manufacturing Practice (GMP), in order to ensure that practitioners in this area consider the wellbeing of patients and produce cell medicinal products that are safe and effective.