THE CONVERGENCE OF STATISTICAL PROCESS CONTROL AND QUANTITATIVE MICROBIAL RISK ASSESSMENT: ENHANCING PHARMACEUTICAL QUALITY AND PUBLIC HEALTH SAFETY

Mostafa EssamEissa

doi:10.22270/ujpr.v10i5.1428

Mostafa EssamEissa Independent Researcher and Consultant, Cairo, Egypt.

10.22270/ujpr.v10i5.1428

Keywords:

data-driven decision-making, infectious disease outbreaks, pharmaceutical quality control, public health risk assessment, risk management, statistical process control

Abstract

Statistical process control (SPC) has become an essential tool for maintaining quality and safety in pharmaceuticals, public health, and other industries. This review critically examines the applications and synergistic potential of SPC applications in pharmaceutical manufacturing and public health risk assessment. The article demonstrates SPC's effectiveness in monitoring microbiological quality, detecting process variations, and assessing public health risks. Key applications include microbiological quality control of pharmaceutical products and water systems, statistical analysis of disinfectant efficacy, and risk assessment for infectious disease outbreaks. SPC can provide a unified analytical framework, facilitates proactive risk management, and supports data-driven decision-making. Future research should focus on developing standardized SPC protocols, integrating SPC with other data analysis tools, and exploring new applications. SPC enables researchers and practitioners to improve pharmaceutical quality and public health outcomes significantly.