Impact of Trend Analysis On Quality Of Finished Products In A Pharmaceutical Industry
DOI:
https://doi.org/10.47430/ujmr.1941.011Keywords:
Microbiology Purity Test,, Trend Analysis,, Paracetamol Syrup,, Pharmaceutical IndustryAbstract
In this study, trend analyses were carried out on the results obtained for microbiology purity tests and assay of 25 batches of Paracetamol Syrup obtained from a selected Pharmaceutical Industry within Minna Metropolis using the 3-Sigma Method. The results of the trend analyses showed the trend ranges of 60±31; 13.6±31 and 102.31±31 for Total Viable Aerobic Mesophilic Bacteria Plate Count, fungi and the assay respectively. The study showed that the results obtained from the trend analyses carried on all the results obtained for microbiology purity tests and assay of 25 batches of Paracetamol Syrup were within the trend ranges calculated and this suggest that the quality of the 25 batches of Paracetamol Syrup analysed were of good quality microbiologically and chemically.
Downloads
References
Akarele, J. O. & Ukoh, G. C. (2002). Aspects of microbial contamination of tablets dispensed in hospitals and community pharmacies in Benin City, Nigeria. Tropical Journal of Pharmaceutical Research, 1(10), 23-28.
https://doi.org/10.4314/tjpr.v1i1.14595
Aulton, M. E. (2002). Pharmaceutics: The Science of Dosage Form Design. 2nd edition. Churchill Livingstone, London, UK.
Bhvani Shankar, L., Gangadharappa, H. V. & Kiran, H. C (2016). Handling of Reserve Samples in Pharmaceutical Industries. International Journal of Pharmaceutical Sciences Review and Research, 37(2), 27-29.
British Pharmacoepeia (2009). Volume IV. In: Microbiological Quality of Pharmaceutical Preparations. Appendix XVID (pp. A426-A427). The Stationery Office, London.
De La Rosa, M. C., Medina, M. R. & Vivar, C. (1995). Microbiological quality of pharmaceutical raw materials. Pharmaceutica Acta Helvetiae, 70(3), 227-232.
https://doi.org/10.1016/0031-6865(95)00022-2
Hugo, W. B. & Russell, A. D. (1998). Pharmaceutical Microbiology. 6th edition. Blackwell Scientific Publications, Oxford, UK.
McGuire, J. L., Hasskarl, H., Bode, G., Klingmann, I. & Zahn, M. (2007). Pharmaceuticals, General Survey. In: Ullmann's Encyclopedia of Chemical Technology. Wiley-VCH, Weinheim.
https://doi.org/10.1002/14356007.a19_273.pub2
Mugoyela, V. & Mwambete, K. D. (2010). Microbial contamination of non-sterile pharmaceuticals in public hospital settings. Therapeutics and Clinical Risk Management, 6, 443-448.
https://doi.org/10.2147/TCRM.S12253
Mwambete, K. D., Justin-Temu, M. & Fazleabbas, S. F. (2009). Microbiological assessment of commercially available quinine Syrups and water for injections in Dar es Salaam, Tanzania. Tropical Journal of Pharmaceutical Research, 8(5), 441-447.
https://doi.org/10.4314/tjpr.v8i5.48088
Obuekwe, C. O, Obuekwe, I. F. & Rafiq, M. (2000). Surface contamination in some common available dosage forms. Medical Principles and Practice, 9(4), 290-299.
https://doi.org/10.1159/000054256
Pradeep, N. (2015). Methods of Identifying Out of Trend Results. In: Investigating Out of Trend Results (pp.8-25). Quality Control (Bio and Chem), Haffkine Bio- Pharma. Corp. Ltd., Mumbai.
Schlegel, H. G. (1994). General Microbiology. 7th edition. Cambridge University Press, UK.
United States Pharmacopeia (USP-62) (2003). Microbiological examination of non- sterile products: Tests for specified microorganisms. Pharmacy Forum, 29(5), 1722-1733.
www.pharmaguidelines.com. Procedure for Investigating Out of Trend Results: Pharmaceutical Guidelines. Accessed on 08/04/2019.
Downloads
Published
How to Cite
Issue
Section
License
Copyright (c) 2023 UMYU Journal of Microbiology Research
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
