Statistical Quality Control Methods and MANOVA: Evaluating Pharmaceutical Quality at Blue Nile Pharmaceutical Company in Sudan (2017-2019)

Abstract

This study evaluates the quality of products manufactured by Blue Nile Pharmaceutical Company in Sudan from 2017 to 2019 using Statistical Quality Control (SQC) tools and Multivariate Analysis of Variance (MANOVA). Samples were collected through a systematic random edge sampling method, focusing on critical quality attributes, including friability, hardness, and chemical composition across various rates and batches. The analysis demonstrated that most quality attributes were stable and met established specifications; however, concerns were identified regarding friability and hardness. MANOVA results (P < 0.05) revealed statistically significant differences based on test type and dosage, while no significant differences were observed between batches, indicating consistent production quality with potential variations influenced by dose and test type. This study provides a comprehensive approach to pharmaceutical quality control by effectively integrating SQC and MANOVA, enabling precise identification of process variations. The findings underscore the necessity of stringent quality control systems and regulatory frameworks to ensure product consistency and reliability in emerging markets. This approach can be adapted by pharmaceutical industries in similar contexts to enhance production quality and mitigate operational risks.