收藏切换
Intelligent transformation of pharmaceutical quality control laboratories: challenges and future trends
收藏切换
PDF
Li-ling HUANG, Yu-qiong KONG, Heng-yuan MA*
Acta Pharmaceutica Sinica | 2024, 59(10) : 2723 - 2729
Less
收藏切换
Acta Pharmaceutica Sinica | 2024, 59(10): 2723-2729
Intelligent transformation of pharmaceutical quality control laboratories: challenges and future trends
Full
Li-ling HUANG, Yu-qiong KONG, Heng-yuan MA*
Affiliations
  • Jiangsu Hengrui Pharmaceuticals Co., Ltd., Lianyungang 222000, China
Published: 2024-10-12 doi: 10.16438/j.0513-4870.2024-0551
Outline
收藏切换

Drug testing involves many analytical instruments and test items, sample pretreatment is tedious, the industry's intelligence level remains low, making drug testing a labour-intensive job. However, in the era of Industry 4.0 intelligent manufacturing, intelligent transformation of the quality control (QC) laboratory has become the focus of industry. At the same time, driven by consistency evaluation of the quality and efficacy of generic drugs and the centralized procurement policies, pharmaceutical companies have intensified their competition, further stimulating the intrinsic demand for laboratory intelligence. Based on the current state and future trends of the pharmaceutical industry, this review discusses the development of a digital and automated QC laboratory. It points out the necessity of transitioning from the traditional centralized laboratory model to an intelligent, distributed quality control model to accommodate continuous manufacturing processes. At the same time, it also analyses the potential challenges in the implementation process and coping strategies, in order to provide relevant practitioners with ideas for building intelligent QC laboratories.

quality control laboratory  /  digitalization  /  automation  /  continuous manufacturing  /  distributed quality control
Li-ling HUANG, Yu-qiong KONG, Heng-yuan MA. Intelligent transformation of pharmaceutical quality control laboratories: challenges and future trends[J]. Acta Pharmaceutica Sinica, 2024 , 59 (10) : 2723 -2729 . DOI: 10.16438/j.0513-4870.2024-0551
Year 2024 volume 59 Issue 10
PDF
256
105
Cite this Article
BibTeX
Article Info
doi: 10.16438/j.0513-4870.2024-0551
  • Receive Date:2024-06-11
  • Online Date:2025-11-24
  • Published:2024-10-12
Article Data
Affiliations
History
  • Received:2024-06-11
  • Revised:2024-07-24
Affiliations
    Jiangsu Hengrui Pharmaceuticals Co., Ltd., Lianyungang 222000, China
References
Share
https://castjournals.cast.org.cn/joweb/yxxb/EN/10.16438/j.0513-4870.2024-0551
Share to
QR

Scan QR to access full text

Cite this article
BibTeX
Citations
表12种不同金属材料的力学参数

Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)

Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
关闭全屏
  • BibTeX
  • EndNote
  • RefWorks
  • TxT