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Technology Transfer as the Process of Pharmaceutical Quality System: Modelling Technology Transfer as a Process Strategy




Author(s)

Valeriy Nikityuk, Eugene Shakin and Tatiana Yarnikh

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DOI:10.17265/2328-2150/2017.06.002

The recent GMP (good medical practice) rules actualisation and its requirements introduction widened the GMP guidelines for every life cycle of medicinal products, including the stage of processes scaling and technology transfer. This requires the technology transfer process to be regulated as the part of pharmaceutical quality system and the following development of corresponding written procedures. The following publication is dedicated to the development of TTP (technology transfer process) and its accessible graphic formalisation alongside the definition of main stages and possible procedures limited by the offered model. According to the actualized GMP rules, the technology transfer is an essential part of pharmaceutical quality system at a modern pharmaceutical company.

Medicine, life cycle, technology transfer, process scaling, pharmaceutical quality system, quality system procedures.

Nikityuk, V., Shakin, E., and Yarnikh, T. 2017. “Technology Transfer as the Process of Pharmaceutical Quality System: Modelling Technology Transfer as a Process Strategy.” Journal of Pharmacy and Pharmacology 5 (6): 299-313.