Resource-Based View of Laboratory Management: Tissue Bank ATMP Production as a Model

Wojciech Smętek, Jacek Węgrzyk, A. Klama-Baryła, W. Łabuś, M. Kraut, Michał Szapski, M. Nowak, D. Kitala
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引用次数: 1

Abstract

Modern health care organizations, e.g., tissue banks, require a resource-based view (RBV) for an efficient stimulation of innovation, productivity, and performance, especially in the context of laboratory management and new product development. High quality advanced therapy medicinal products (ATMPs) are expected to bring important health benefits; therefore, their production has to be performed in accordance with good manufacturing practice (GMP). Although there are no precisely defined criteria for quality control/evaluation methods of obtained ATMPs, all aspects of pharmaceutical quality of ATMPs’ development, manufacturing, distribution, inspection, and review processes ought to be strictly fulfilled. Explicit performance management and production regimes in accordance with pharmacopeia and RBV philosophy have been proposed in this chapter.
实验室管理的资源观:以组织库ATMP生产为模型
现代卫生保健组织,例如组织库,需要基于资源的观点(RBV)来有效地刺激创新、生产力和绩效,特别是在实验室管理和新产品开发的背景下。高质量的先进治疗药物(atmp)有望带来重要的健康效益;因此,它们的生产必须按照良好生产规范(GMP)进行。虽然对获得的atmp的质量控制/评价方法没有精确定义的标准,但atmp的开发、制造、销售、检验和评审过程的各个方面的药品质量都应严格执行。本章根据药典和RBV理念提出了明确的绩效管理和生产制度。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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