Statistical Quality Control for Drug Ingredients: A Modern Approach

Current Perspective in Quality Control Examining and Extended Researching for Certain Aspects of Active Pharmaceutical Ingredient Using Statistical Process Control

Control charts are an important part of statistical control because they allow the inspection characteristics of manufactured pharmaceutical products to be tracked and controlled. It helps show current processes and status and, if necessary, identifies areas for further development. The investigation and analysis of an initial trend for a few inspection properties of the manufactured chemical 3-O-ethyl 5-O-methyl 2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulfonic acid is the main focus of the current work. Using the well-known commercial SPC platform for comprehensive SPC analyses. The datasets of the assay and polarization rotation followed the Weibull pattern. While the results of the overall impurities and particle size test data were adopted for Gaussian spreading the Johnson family transformation was implemented for the latter. An exploratory Individual-Moving Range plot is the method used to trend the datasets and capacity analyses were conducted in accordance with that method. Improvements are required to enhance the quality of inspection properties at the preliminary steps since there are signs of a low capability process in the particle size test and the assay to some extent. In addition, the means of the quality tests should be brought to the center since the preliminary data are not in the middle of the specification range. Thus, some inspection characteristics are lower quality than others and need immediate correction and enhancement at the initial stages of the establishment of the manufacturing process and criteria. This perspective highlights the importance of control charts in the examination of the quality of chemically manufactured materials.