新興生醫產品之品質要求：GTP與GMP之比較 | 合法醫療器材資訊網

由羅瑋瑜著作·2018—新興生醫產品之品質要求：GTP與GMP之比較...產品；人體細胞組織優良操作規範；西藥藥品優良製造作業規範；advancedtherapymedicinalproducts；GTP；GMP.

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...