From a regulatory perspective, drug quality consistency evaluation must concern different processes used for the same drug. In this study, an assessment strategy based on quality by design (QbD) was developed for population pharmaceutical quality evaluation. A descriptive analysis method based on QbD concept was first established to characterize the process by critical evaluation attributes (CEAs). Then quantitative analysis method based on an improved statistical process control (SPC) method was established to investigate the process indicators (PIs) in the process population, such as mean distribution, batch-to-batch difference and abnormal quality probability. After that rules for risk assessment were established based on the SPC limitations and parameters. Both the SPC parameters of the CEAs and the risk of PIs were visualized according to the interaction test results to obtain a better understanding of the population pharmaceutical quality. Finally, an assessment strategy was built and applied to generic drug consistency assessment, process risk assessment and quality trend tracking. The strategy demonstrated in this study could help reveal quality consistency from the perspective of process control and process risk, and further show the recent development status of domestic pharmaceutical production processes. In addition, a process risk assessment and population quality trend tracking provide data-based information for approval. Not only can this information serve as a further basis for decision-making by the regulatory authority regarding early warnings, but it can also reduce some avoidable adverse reactions. With continuous addition of data, dynamic population pharmaceutical quality is meaningful for emergencies and decision-making regarding drug regulation.

从监管角度来看，药品质量一致性评价必须关注同一药品的不同工艺。在本研究中，开发了一种基于质量源于设计（QbD）的评估策略，用于人群药物质量评估。首先建立了基于QbD概念的描述性分析方法，通过关键评估属性（CEA）来表征过程。然后建立基于改进的统计过程控制（SPC）方法的定量分析方法，研究过程总体中的过程指标（PI），如均值分布、批次间差异和异常质量概率。之后，根据 SPC 的限制和参数建立了风险评估规则。根据相互作用测试结果，对CEA的SPC参数和PI风险进行可视化，以更好地了解群体药品质量。最后，建立了评估策略并应用于仿制药一致性评估、工艺风险评估和质量趋势跟踪。本研究论证的策略有助于从过程控制和过程风险的角度揭示质量一致性，并进一步展示国内药品生产过程的最新发展状况。此外，流程风险评估和人口质量趋势跟踪提供基于数据的信息以供审批。这些信息不仅可以作为监管部门预警决策的进一步依据，还可以减少一些本可避免的不良反应。随着数据的不断添加，动态的群体药品质量对于紧急情况和药品监管决策具有重要意义。