Intelligent transformation of pharmaceutical quality control laboratories: challenges and future trends
10.16438/j.0513-4870.2024-0551
- VernacularTitle:药品质量控制实验室的智能化转型: 挑战与未来趋势
- Author:
Li-ling HUANG
;
Yu-qiong KONG
;
Heng-yuan MA
- Publication Type:Research Article
- Keywords:
quality control laboratory;
igitalization;
automation;
continuous manufacturing;
istributed quality control
- From:
Acta Pharmaceutica Sinica
2024;59(10):2723-2729
- CountryChina
- Language:Chinese
-
Abstract:
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.
