Acta Nat. Sci.   |  e-ISSN: 2718-0638

Original article | Acta Natura et Scientia 2024, Vol. 5(1) 31-40

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

Mostafa Eissa

pp. 31 - 40   |  Manu. Number: MANU-2312-28-0010.R1

Published online: May 22, 2024  |   Number of Views: 24  |  Number of Download: 159


Abstract

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.

Keywords: Capability plot, Johnson transformation, Individual-Moving Range, Normal probability, Weibull distribution


How to Cite this Article?

APA 6th edition
Eissa, M. (2024). Current Perspective in Quality Control Examining and Extended Researching for Certain Aspects of Active Pharmaceutical Ingredient Using Statistical Process Control . Acta Natura et Scientia, 5(1), 31-40.

Harvard
Eissa, M. (2024). Current Perspective in Quality Control Examining and Extended Researching for Certain Aspects of Active Pharmaceutical Ingredient Using Statistical Process Control . Acta Natura et Scientia, 5(1), pp. 31-40.

Chicago 16th edition
Eissa, Mostafa (2024). "Current Perspective in Quality Control Examining and Extended Researching for Certain Aspects of Active Pharmaceutical Ingredient Using Statistical Process Control ". Acta Natura et Scientia 5 (1):31-40.

References
  1. 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/ [Google Scholar]
  2. Amlodipine Monograph for Professionals. (2016). amLODIPine (Monograph). Retrieved on June 4, 2016, from https://www.drugs.com/monograph/amlodipine.html [Google Scholar]
  3. British Pharmacopoeia. (2022). British Pharmacopoeia 2022. Retrieved on January 1, 2022, from https://www.pharmacopoeia.com/ [Google Scholar]
  4. 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 [Google Scholar] [Crossref] 
  5. Eissa, M. (2017). Bioburden control in the biopharmaceutical industry. BioPharm International, 30(9), 24-27. [Google Scholar]
  6. Eissa, M. (2018c). Evaluation of microbiological purified water trend using two types of control chart. European Pharmaceutical Review, 23(5), 36-38. [Google Scholar]
  7. 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 [Google Scholar] [Crossref] 
  8. 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.               [Google Scholar]
  9. 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 [Google Scholar] [Crossref] 
  10. 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 [Google Scholar] [Crossref] 
  11. Eissa, M. E. (2018b). Adulterated pharmaceutical product detection using statistical process control. Bangladesh Pharmaceutical Journal, 21(1), 7-15. [Google Scholar]
  12. 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. [Google Scholar]
  13. 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 [Google Scholar] [Crossref] 
  14. 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 [Google Scholar] [Crossref] 
  15. 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. [Google Scholar]
  16. 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. [Google Scholar]
  17. 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 [Google Scholar] [Crossref] 
  18. 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. [Google Scholar]
  19. 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. [Google Scholar]
  20. 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 [Google Scholar] [Crossref] 
  21. 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 [Google Scholar] [Crossref] 
  22. 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. [Google Scholar]
  23. 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 [Google Scholar] [Crossref] 
  24. 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. [Google Scholar]
  25. 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/ [Google Scholar]
  26. 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 [Google Scholar]
  27. Goldman, L., & Schafer, A. I. (2019) Goldman-Cecil Medicine e-book. Elsevier Health Sciences. [Google Scholar]
  28. 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 [Google Scholar] [Crossref]