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 techno...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.展开更多
To evaluate the impact of GMP on Chinese pharmaceutical industry in a quantitative system, we referred to theories on policy evaluation and industrial organization, and conducted literature review, key person intervie...To evaluate the impact of GMP on Chinese pharmaceutical industry in a quantitative system, we referred to theories on policy evaluation and industrial organization, and conducted literature review, key person interview, multi-round Delphi and field investigation. We set up the principles to construct our indicator system, reviewed based on the policy objectives of the new GMP for drugs systematically, and analysed the influence path of the new GMP for pharmaceutical manufacturers. We proposed a three-dimensional ＂structure-conduct-performance＂ evaluation indicator system. Our evaluation indicator system is accepted by experts and relevant personnel, indicating the three-dimensional evaluation indicator system is feasible to evaluate the impact of the new GMP in Chinese pharmaceutical industry.展开更多
文摘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.
文摘To evaluate the impact of GMP on Chinese pharmaceutical industry in a quantitative system, we referred to theories on policy evaluation and industrial organization, and conducted literature review, key person interview, multi-round Delphi and field investigation. We set up the principles to construct our indicator system, reviewed based on the policy objectives of the new GMP for drugs systematically, and analysed the influence path of the new GMP for pharmaceutical manufacturers. We proposed a three-dimensional ＂structure-conduct-performance＂ evaluation indicator system. Our evaluation indicator system is accepted by experts and relevant personnel, indicating the three-dimensional evaluation indicator system is feasible to evaluate the impact of the new GMP in Chinese pharmaceutical industry.
