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Bio-Design and Manufacturing  2023 Vol.6 No.5 P.609615

http://doi.org/10.1007/s42242-023-00248-0


Pharmaceutical digital transformation in China: digital quality assurance takes the drivers 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):  School of Business Administration, Shenyang Pharmaceutical University, Shenyang 110016, China; more

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 drivers seat[J]. Journal of Zhejiang University Science D, 2023, 6(5): 609615.

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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.

沈阳药科大学袁红梅、上海药品审评核查中心陈桂良团队 | 中国制药业的数字化转型:数字化质量保证崭露头角——“数字化转型正当时”

本文聚焦中国制药业的数字化转型发展。随着自动化、物联网(IoT)、人工智能(AI)、大数据等数字技术的发展,数字化越来越成为推动经济社会发展的核心驱动力。生物医药行业必须以数字化技术为引领,科学创新、深入实践,促进药品安全治理体系共建共享、互联互通,提高风险管理的预见性、靶向性、时效性。数字化质量保证(简称DQA)已逐步成为药品生命周期风险管理链条中最关键的步骤之一。在大量文献综述、问卷调查和专家共识的基础上,上海药品审评核查中心连同行业专家共同商讨制定《药品生产数字化质量保证技术要求》。该标准是我国药品数字化方面的首个团体标准,标准首次明确了DQA的概念和技术要求,填补了国内药品数字化领域空白。DQA作为一种自动化的GMP符合性评估工具,对主导GMP数字化具有重要的现实意义,可以加快国内医药行业的高质量现代化发展,有利于更加精准而且自动化的事前预警、事中控制、事后分析评价,对药品质量风险防控具有积极意义。该标准执行企业应用标准的实施成效显著,于2022年12月被收载为“上海标准”。

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