Current Perspective in Quality Control Examining and Extended Researching for Certain Aspects of Active Pharmaceutical Ingredient Using Statistical Process Control
Keywords:
Capability plot, Johnson transformation, Individual-Moving Range, Normal probability, Weibull distributionAbstract
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.
References
Advantive. (2023). Capability indices: Ppk. Advantive. Retrieved on August 18, 2023, from https://www.advantive.com/solutions/spc-software/quality-advisor/data-analysis-tools/ppk/
Amlodipine Monograph for Professionals. (2016). amLODIPine (Monograph). Retrieved on June 4, 2016, from https://www.drugs.com/monograph/amlodipine.html
British Pharmacopoeia. (2022). British Pharmacopoeia 2022. Retrieved on January 1, 2022, from https://www.pharmacopoeia.com/
Eissa, D., Rashed, E., & Eissa, M. (2023). Measuring public health effect of coronavirus disease 2019: A novel perspective in healthcare in pandemic times. Medical Journal of Western Black Sea, 7(2), 266-268. https://doi.org/10.29058/mjwbs.1257163
Eissa, M. (2017). Bioburden control in the biopharmaceutical industry. BioPharm International, 30(9), 24-27.
Eissa, M. (2018c). Evaluation of microbiological purified water trend using two types of control chart. European Pharmaceutical Review, 23(5), 36-38.
Eissa, M. (2021). Implementation of modified Q-control chart in monitoring of inspection characteristics with finite quantification sensitivity limits: A case study of bioburden enumeration in capsule shell. El-Cezeri, 8(3), 1093-1107. https://doi.org/10.31202/ecjse.871179
Eissa, M. (2022). Establishment of biocidal activity evaluation study protocol in healthcare facility for routine monitoring of antibacterial activity of disinfectants. Journal of Experimental and Clinical Medicine, 39(4), 939-947.
Eissa, M. E. (2015). Shewhart control chart in microbiological quality control of purified water and its use in quantitative risk evaluation. Pharmaceutical and Biosciences Journal, 4(1), 45-51. https://doi.org/10.20510/ukjpb/4/i1/87845
Eissa, M. E. (2016 2016a). Novel rapid method in ecological risk assessment of air-borne bacteria in pharmaceutical facility. Mahidol University Journal of Pharmaceutical Sciences, 43(3), 115-126. https://doi.org/10.14456/mujps.2016.14
Eissa, M. E. (2018b). Adulterated pharmaceutical product detection using statistical process control. Bangladesh Pharmaceutical Journal, 21(1), 7-15.
Eissa, M. E. (2018d). Variable and attribute control charts in trend analysis of active pharmaceutical components: Process efficiency monitoring and comparative study. Experimental Medicine, 1(1), 32-44.
Eissa, M. E. (2023a). Studies on morbidities and mortalities from COVID-19: Novel public health practice during pandemic periods. Asian Journal of Applied Sciences, 16(3), 84-94. https://doi.org/10.3923/ajaps.2023.84.94
Eissa, M. E. (2023b). Trending perspective in evaluation of inspection characteristics of pharmaceutical compound: comparative study of control charts. Universal Journal of Pharmaceutical Research, 8(5), 15-21. https://doi.org/10.22270/ujpr.v8i5.1006
Eissa, M. E. A. (2019). Food outbreak: An overview on selected cases over long-term web-based monitoring. SM Journal of Nutrition and Metabolism, 5(1), 1029.
Eissa, M. E. A. M. (2018a). Conventional culture media: an outdated microbiological tool but still useful. International Journal of Drug Safety and Discovery, 2(2), 011.
Eissa, M. E., & Abid, A. M. (2018). Application of statistical process control for spotting compliance to good pharmaceutical practice. Brazilian Journal of Pharmaceutical Sciences, 54(2), e17499. https://doi.org/10.1590/s2175-97902018000217499
Eissa, M. E., Mahmoud, A. M., & Nouby, A. S. (2016b). Control chart in microbiological cleaning efficacy of pharmaceutical facility. Dhaka University Journal of Pharmaceutical Sciences, 14(2), 133-138.
Eissa, M. E., Seif, M., & Fares, M. (2015). Assessment of purified water quality in pharmaceutical facility using six sigma tools. International Journal of Pharmaceutical Quality Assurance, 6(2), 54-72.
Eissa, M., & Mahmoud, A. (2016). Evaluation of microbial recovery from raw materials for pharmaceutical use. Journal of Food and Pharmaceutical Sciences, 4(1), 6-11. https://doi.org/10.14499/jfps
Eissa, M., & Rashed, E. (2023). Evaluation of microbiological cleanliness of machines/equipment through rinse technique using statistical process control. EMU Journal of Pharmaceutical Sciences, 6(1), 1–12. https://doi.org/10.54994/emujpharmsci.1196909
Eissa, M., Mahmoud, A., & Nouby, A. (2016a). Evaluation and failure risk of microbiological air quality in production area of pharmaceutical plant. RGUHS Journal of Pharmaceutical Sciences, 5, 155-166.
Eissa, M., Rashed, E., & Eissa, D. E. (2021a). Study of tellurium-129m (129mTe) ground deposition following Fukushima nuclear disaster: descriptive analysis of UNSCEAR database using statistical process techniques. Mugla Journal of Science and Technology, 7(2), 67-72. https://doi.org/10.22531/muglajsci.955946
Eissa, M., Rashed, E., & Eissa, D. E. (2021b). Quality improvement in routine inspection and control of healthcare products using statistical intervention of long-term data trend. Dicle University Journal of the Institute of Natural and Applied Sciences, 10(2), 163-184.
Essam, M. (2019). A novel approach in assessing the antimicrobial efficacy of eye drop products. European Pharmaceutical Review. Retrieved on January 23, 2019, from https://www.europeanpharmaceuticalreview.com/article/40864/novel-approach-assessing-antimicrobial-efficacy-eye-drop-products/
Essam, M. (2023). Pharmaceutical component kinetics. Pharma Focus Asia. Retrieved on July 11, 2023, from https://www.pharmafocusasia.com/articles/pharmaceutical-component-kinetics-inventory-dynamic-control-is-crucial
Goldman, L., & Schafer, A. I. (2019) Goldman-Cecil Medicine e-book. Elsevier Health Sciences.
Mostafa Eissa, M. E. A. (2018, May 22). Quality criteria establishment for dissolution of ascorbic acid from sustained release pellets. Novel Techniques in Nutrition & Food Science, 2(2), 137-142. https://doi.org/10.31031/ntnf.2018.02.000531