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

作　　者：Valeriy Nikityuk Eugene Shakin Tatiana Yamikh 

机构地区：[1]SCC "VADEMECUM" Ltd, Kyiv 02140, Ukraine [2]National University of Pharmacy, Kharkiv 61002, Ukraine

出　　处：《Journal of Pharmacy and Pharmacology》2017年第6期299-313,共15页药剂与药理学（英文版）

摘　　要：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 modem pharmaceutical company.

关 键 词：MEDICINE life cycle technology transfer process scaling pharmaceutical quality system quality system procedures. 

分 类 号：F124.3[经济管理—世界经济] TB9[一般工业技术—计量学]