A strategy for population pharmaceutical quality assessment based on quality by design.

ABSTRACT: 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 th

SUBMITTER: Zhao Y 

PROVIDER: S-EPMC8572710 | biostudies-literature | 2021 Oct

REPOSITORIES: biostudies-literature