JZUS - Journal of Zhejiang University SCIENCE

Journal of Zhejiang University SCIENCE

Accepted manuscript available online (unedited version)

Pharmaceutical digital transformation in China: Digital Quality Assurance Takes the Driver’s Seat

Author(s): Yuanyuan Ge, Meng Cao, Hui Cao, Bin Han, Jingchen Zhang, Zhengyu Yi, Yaowei Wu, Beifen Zhu, Keping Ruan, Yiyi Pu, Yi Zeng, Tongjing Tao, Zhenzhong Lyu, Hongmei Yuan, Guiliang Chen
Affiliation(s): Shenyang Pharmaceutical University, Shenyang 110016, China; Shanghai Center for Drug Evaluation and Inspection, Shanghai 201203, China; Shanghai Pharmaceutical Profession Association, Shanghai 200003, China; Sanofi (China) Investment Co., Ltd., Shanghai 200040, China; Shanghai Dendreon Biopharmaceuticals, Shanghai 201203, China; Shanghai Cellular Biomedicine Group, Shanghai 201203, China; Fosun Kite Biotechnology, Shanghai 201203, China; Merck Pharmaceuticals, Nantong 226000 , China
Corresponding email(s): yuanhm612@163.com, chenguiliang@smda.sh.cn
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Yuanyuan Ge, Meng Cao, Hui Cao, Bin Han, Jingchen Zhang, Zhengyu Yi, Yaowei Wu, Beifen Zhu, Keping Ruan, Yiyi Pu, Yi Zeng, Tongjing Tao, Zhenzhong Lyu, Hongmei Yuan, Guiliang Chen. Pharmaceutical digital transformation in China: Digital Quality Assurance Takes the Driver’s Seat[J]. Journal of Zhejiang University Science ,in press.Frontiers of Information Technology & Electronic Engineering,in press.https://doi.org/10.1007/s42242-023-00037-X

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author="Yuanyuan Ge, Meng Cao, Hui Cao, Bin Han, Jingchen Zhang, Zhengyu Yi, Yaowei Wu, Beifen Zhu, Keping Ruan, Yiyi Pu, Yi Zeng, Tongjing Tao, Zhenzhong Lyu, Hongmei Yuan, Guiliang Chen",
journal="Journal of Zhejiang University Science ",
year="in press",
publisher="Zhejiang University Press & Springer",
doi="https://doi.org/10.1007/s42242-023-00037-X"
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%A Yuanyuan Ge
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%A Bin Han
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%A Hongmei Yuan
%A Guiliang Chen
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A1 - Yaowei Wu
A1 - Beifen Zhu
A1 - Keping Ruan
A1 - Yiyi Pu
A1 - Yi Zeng
A1 - Tongjing Tao
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Abstract
Chinese Summary
Academic Network
Reviewer Comment

Abstract: The development of automation, the Internet of Things (IoT), artificial intelligence (AI), big data, and other digital technologies has made it imperative for pharmaceutical companies to undergo digital transformation to improve their research and development capabilities, increase the quality of their products, lower operating costs, and gain a competitive edge. One of the most crucial steps in the life-cycle risk management chain for drugs is digital quality assurance (DQA). Based on a literature review, questionnaire survey, and expert consensus, a panel of experts was convened in Shanghai to generate a set of conceptual, pharmaceutical manufacturing-specific DQA specifications. The goal of the consensus is to advance common practices that use digital tools to quickly collect, record, evaluate, and review particular forms of data to enhance the automation of quality assurance and make drug quality activities more efficient.

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