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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. [ABSTRACT FROM AUTHOR]

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-Omethyl 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. [ABSTRACT FROM AUTHOR]

Gramicidin is a polypeptide antibiotic composed of a mixture of antimicrobial compounds. Thus, its antibacterial activity is preferentially assessed using a microbiological assay. The aim of this study is targeting to establish and validate a microbiological potency for Gramicidin with a view to the employment of a simple method with more than two folds output per test run (if compared with symmetrical designs) using 3×1 experimental designs with reasonably statistically acceptable results. The validation criteria of gramicidin turbidimetric assay using the USP method were tested in terms of selectivity, linearity, accuracy, precision and robustness. Moreover, the consistency of the experimental groups was examined in terms of error and difference from the target labelled concentration of 0.25 mg g-1 value, in addition to the uncertainty factor. Verification of the assay suitability was evaluated statistically against reference antibiotics of known activity. Calibration of the analytical curve showed a coefficient of correlation (r) = 0.9980 with none of the relative standard deviations (RSD) values greater than three. There was no observable fixed or variable deviation in the absorbance measurement with concentration increment. The accuracy output and profile were evaluated over ranges 50%, 100% and 150% having a maximum RSD of around three with reasonable results, confidence and absence of concentration-related bias. Robustness, precision and suitability verification were evaluated with no outliers and all RSDs below five. The turbidimetric assay design of 3×1 for gramicidin showed acceptable validation parameters and could be used as a substitute design for conventional higher-level parallel line assay models. [ABSTRACT FROM AUTHOR]

Monitoring the quality criteria in the healthcare industry and the pharmaceutical field specifically is a crucial mission activity to ensure the delivery of safe and effective treatment to patients with predictable and acceptable medicinal properties. One of the critical ingredients that are found in many activities is water. In the present study, the inspection characteristic trend was monitored by collecting results of the microbial count of Purified Water (PW) at two points in the water treatment station. The dataset was examined for pattern and distribution after processing and stratification and before conducting transformation using Microsoft Excel. Then, control charts were constructed using Statistical Process Control (SPC) software. The results showed that transformation improved data normalization for the Individual-Moving Range (I-MR) chart while the original pattern of the dataset was lost distorted. On the other hand, other advantages could be retained when using the Laney chart where no transformation was implemented on original raw data. The selection should be based on the nature of the process aim and condition. [ABSTRACT FROM AUTHOR]