Chapters authored
Resource-Based View of Laboratory Management: Tissue Bank ATMP Production as a Model
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.
Part of the book: Biochemical Testing