Assessment of Some Inspection Properties of Commonly Used Medicinal Excipients Using Statistical Process Control for Monitoring of Manufacturer Quality
Keywords:
Box plot, Bubble plot, Control chart, Contour plot, Corn starch, SPCAbstract
This study is a component of a larger initiative that involves the assessment and screening of pharmaceutical and chemical factories that produce medical substances, particularly in Asia and export them to poor nations. The present study concentrated on the inactive pharmaceutical ingredients of a frequently used excipient in pharmaceutical products made of amylopectin and amylose, named Amylum Maydis by the International Union of Pure and Applied Chemistry (IUPAC) nomenclature. This compound has the chemical formula C6H10O5. Manufacturers asserted that all raw ingredients complied with the British Pharmacopoeia (BP), harmonizing requirements and analytical criteria in the process. As a result, every test complied with the official standard procedures described in the raw material testing monograph. The chosen tests included oxidizing agents, sulfated ash, and loss on drying (LOD). Software for statistical process control, or SPC, was used to collect and handle datasets. Preliminary data examination was done using box plots and three variable visualization techniques associated with the correlation matrix. All results showed that improvements of the inspection characteristics records are mandated to show stable variations even if there was no out-of-specification detected. Accordingly, the output of the tests should be investigated to correct for the assignable causes of the variations. It should be noted that the present data did not follow specific distributions, especially with the presence of aberrant values. Furthermore, it was found that there were several out-of-control points even in cases where there was no deviation from the specification, highlighting the need for suitable inquiry and correction for assignable reasons of variances among batches. Government enforcement of industrial SPC regulations is necessary to ensure the safety and quality of produced medical substances.
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