Tracking Stability Using Shewhart Charts to Elucidate Trending Patterns in Glyceryl Guaiacolate Assay: Paving the Way for Quality Improvement in Medicinal Chemical Industry

Yazarlar

DOI:

https://doi.org/10.61326/actanatsci.v5i2.314

Anahtar Kelimeler:

Control chart- Glyceryl guaiacolate- SPC- Out-of-control- Capability analysis

Özet

Shewhart charts are a crucial part of statistical process control, or SPC, which tracks and regulates the pharmaceutical compound’s inspection properties. It serves to shed light on the process’s present state and, if necessary, the future improvements that will be needed. The trending pattern for the glyceryl guaiacolate assay is the main subject of this investigation. SPC software is used in this work. Following the selection of the most appropriate underlying distribution, Individual-Moving Range (I-MR) charts are used as a trending method for the data. Since some batches in the time series sequence show indications of out-of-control points, improvements are needed to enhance the quality of inspection attributes. Accordingly, capability analysis will not be relied on at this stage till the stabilization of the process. This study highlights the vital role of control charts in ensuring the quality of chemical materials. It contributes to building a robust industrial regulatory system by analyzing the quality of medicinal compounds from chemical manufacturers, especially in developing countries.

Referanslar

Eissa, D., Rashed, E., & Eissa, M. (2023). Measuring public health effect of coronavirus disease 2019: A novel perspective in healthcare in pandemic times. Batı Karadeniz Tıp Dergisi, 7(2), 266–268. https://doi.org/10.29058/mjwbs.1257163

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. (2018a). Quality criteria establishment for dissolution of ascorbic acid from sustained release pellets. Novel Techniques in Nutrition & Food Science, 2(2). http://doi.org/10.31031/ntnf.2018.02.000531

Eissa, M. E. (2018b). Variable and attribute control charts in trend analysis of active pharmaceutical components: Process efficiency monitoring and comparative study. Experimental Medicine, 1(1), 32–44. https://doi.org/10.31058/j.em.2018.11003

Eissa, M. E. (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. (2021a). 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 Journal of Science and Engineering, 8(3), 1093–1107. https://doi.org/10.31202/ecjse.871179

Eissa, M. (2021b). Implementation of trending charts in analysis of inventory pattern. European Pharmaceutical Review, 26(2), 30–33.

Eissa, M. (2021c). Statistical comparison of parallel-line symmetrical microbiological models: Analysis of agar diffusion assay in 8 x 8 large rectangular plates. İstatistik ve Uygulamalı Bilimler Dergisi, 2(2), 48–64. https://doi.org/10.52693/jsas.989584

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. https://doi.org/10.52142/omujecm.39.4.4

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. (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., & Abid, A. M. (2018). Application of statistical process control for spotting compliance to good pharmaceutical practice. Brazilian Journal of Pharmaceutical Sciences, 54(02), e17499. https://doi.org/10.1590/s2175-97902018000217499

Eissa, M. E., & Hamed, H. S. (2019). Application of statistical quality control tools for monitoring of pharmaceutical product properties. Biological Sciences-PJSIR, 62(1), 39–48. https://doi.org/10.52763/PJSIR.BIOL.SCI.62.1.2019.39.48

Eissa, M. E., & Mahmoud, A. M. (2015). Assessment of modified preservation formulae after optimizing preliminary neutralization evaluation study. International Journal of Multidisciplinary Research Studies and Developments, 1(2), 5–11.

Eissa, M. E., & Rashed, E. R. (2023). Analysis and modeling of morbidity and mortality from coronavirus outbreak in Brazil: A case study of public health challenge using unique statistical tools. Journal of Health Science Research, 8(2), 57–61. https://doi.org/10.25259/JHSR_3_2023

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. https://doi.org/10.3329/dujps.v14i2.28501

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. (2020). Application of statistical process optimization tools in inventory management of goods quality: Suppliers evaluation in healthcare facility. Journal of Turkish Operations Management, 4(1), 388–408.

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. https://doi.org/10.5530/rjps.2015.4.5

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. Muğla 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 Üniversitesi Fen Bilimleri Enstitüsü Dergisi, 10(2), 163–184.

Rashed, E. R., & Eissa, M. E. (2020). Long-term monitoring of cancer mortality rates in USA: A descriptive analysis using statistical process control tools. Iberoamerican Journal of Medicine, 2(2), 55–60. https://doi.org/10.53986/ibjm.2020.0012

Yayınlanmış

2024-11-24

Nasıl Atıf Yapılır

Essam Eissa, M. (2024). Tracking Stability Using Shewhart Charts to Elucidate Trending Patterns in Glyceryl Guaiacolate Assay: Paving the Way for Quality Improvement in Medicinal Chemical Industry. Acta Natura Et Scientia, 5(2), 119–124. https://doi.org/10.61326/actanatsci.v5i2.314

Sayı

Bölüm

Kısa Bildiri