What is it about?
This study assessed the quality of commonly used medicinal excipients from the chemical manufacturing company in Asia, particularly Amylum Maydis, from Asian manufacturers supplying low- and middle-income countries. The study used Statistical Process Control (SPC) to monitor the quality of the excipients. The results showed that improvements are needed in the inspection characteristics records to show stable variations. The output of the tests should be investigated to correct for the assignable causes of the variations. The study highlights the need for suitable inquiry and correction for assignable reasons of variances among batches. The study recommends government enforcement of industrial SPC regulations to ensure the safety and quality of produced medical substances.
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Why is it important?
This research is crucial because it focuses on ensuring the quality and safety of essential medicines, particularly in low- and middle-income countries that often rely on imports from Asia. Here's why: Protecting Vulnerable Populations: These countries may have limited resources for drug quality control, making them more susceptible to receiving substandard or counterfeit medications. Identifying and Addressing Manufacturing Issues: By using Statistical Process Control (SPC), the study aims to pinpoint potential problems in the manufacturing process of a common excipient (Amylum Maydis). This proactive approach helps prevent issues before they lead to substandard drugs. Improving Manufacturing Practices: The findings will encourage manufacturers to implement better quality control measures, leading to more consistent and reliable drug production. Enforcing Regulations: The study highlights the need for stronger government oversight and enforcement of quality standards within the pharmaceutical industry, especially for manufacturers supplying these vulnerable regions. In essence, this research contributes to a safer and more reliable supply of essential medicines, ultimately improving public health in low- and middle-income countries.
Perspectives
Some important unique perspectives from the "Assessment of Some Inspection Properties of Commonly Used Medicinal Excipients Using Statistical Process Control for Monitoring of Manufacturer Quality" document: The study is part of a larger initiative focused on evaluating and screening pharmaceutical and chemical factories, particularly in Asia, that export medical substances to poorer nations. The research specifically examines inactive pharmaceutical ingredients, using a common excipient in pharmaceutical products made of amylopectin and amylose, known as Amylum Maydis. The study uses statistical process control (SPC) software to gather and analyze datasets. Preliminary data analysis includes the use of box plots and three-variable visualization techniques related to the correlation matrix. The findings indicate that improvements in inspection characteristics are needed to achieve stable variations, even when no out-of-specification results were detected. The data analyzed did not follow specific distributions, particularly due to the presence of outliers. The study highlights the presence of several out-of-control points, even in cases without deviations from specifications, emphasizing the need for investigation and correction of variance causes among batches. The document advocates for government enforcement of industrial SPC regulations to ensure the safety and quality of produced medical substances.
Independent Researcher & Consultant Mostafa Essam Eissa
Read the Original
This page is a summary of: Assessment of Some Inspection Properties of Commonly Used Medicinal Excipients Using Statistical Process Control for Monitoring of Manufacturer Quality, Acta Natura et Scientia, May 2024, Prensip Publishing,
DOI: 10.61326/actanatsci.v5i1.3.
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