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Principles of Good Manufacturing Practice

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Biomedical Product Development: Bench to Bedside

Abstract

In the middle ages, craftsmen were responsible for manufacturing and inspecting their products, and the quality was considered as their own honor. Industrial revolution altered the concept of quality drastically. Rise of inspections and separation of quality departments were the main outcomes of this alteration. On the other hand, statistical methods were the unprecedented approach to control the products variabilities and quality. In addition to statistical methods, “quality control” and “quality management” as novel concepts were the other achievements in the late nineteenth century. Actually, quality has been considered as an organizational idea, and in this organization all participants are responsible. Nowadays, with regard to ever developing and competitive atmosphere, the importance of quality policies and objectives is fully recognized, and also quality management system has been prominent everywhere from research to business and in every aspect of life. This chapter discusses the importance of quality and its performance in our lives and provides a brief description and background of GMP and some basic principles of GMP, guidelines, and modules.

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    Correspondence to Babak Arjmand .

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    Sarvari, M., Alavi-Moghadam, S., Larijani, B., Rezazadeh, I., Arjmand, B. (2020). Principles of Good Manufacturing Practice. In: Arjmand, B., Payab, M., Goodarzi, P. (eds) Biomedical Product Development: Bench to Bedside. Learning Materials in Biosciences. Springer, Cham. https://doi.org/10.1007/978-3-030-35626-2_6

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