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Cell processing is an important function within the organization and should be carefully evaluated on a continuous basis. Tissue and cell establishments should strive to develop quality risk management systems within their regulated environment. An effective quality management system provides a proactive and systematic means of identify, analyze and evaluate potential process and product risks during the development, testing, processing, preservation and distribution of the tissue or cells.
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Scope and Importance
The regulation of substances of human origin such as blood, tissues, cells and organs at a European Union (EU) level became legally possible when the treaty of the EU was embedded in 1995 by article 152 of the Treaty of Amsterdam. This article extended the legal competence of the EU to certain aspects of health care stating that “Measures setting high standards of quality and safety of organs and substances of human origin, blood and blood derivatives” would be adopted.
The global stem cell therapy market on the basis of the mode of treatment is segmented into allogeneic and autologous stem cell therapy. The allogeneic stem cell therapy is expected to command the largest share of the market in 2015, and the allogeneic stem cell therapy segment is expected to grow at the highest CAGR of 40% in the forecast period (2015-2020).
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