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INTERNATIONAL JOURNAL OF PHARMACEUTICAL RESEARCH

A Step Towards Excellence
Published by : Advanced Scientific Research
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0975-2366
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IJPR 9[3] July - September 2017 Special Issue

July - September 9[3] 2017

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Improving Shelf Life of Pharmaceutical products with Six Sigma: A Case study

Author: ABDALLAH ABDALLAH
Abstract: Six sigma has been used for the last few decades to save operational cost, resolve quality issues, and improve customer satisfaction. In this article, we review how six sigma can be used to improve shelf life for pharmaceutical products. Six sigma uses a structured methodology consisting of five phases: Define, Measure, Analyze, improve and Control. In each phase, specific managerial and quality tools are used to achieve needed performance improvement. Shelf life of pharmaceutical products is considered one of the most important performance indicators for all drug manufacturers, especially for exported products. In this research, we use a typical six sigma methodology in a case study to improve shelf life for an antibiotic that used to have a shelf life of 18 months. The antibiotic contains two active ingredients: Amoxicillin and Clavulanic acid. Six sigma project was able to study the chemical and physical structure of the product along with the manufacturing process in order to come up with solutions for the low shelf life problem. At the end of the project, this product showed a shelf life of 32 months in initial stability studies.
Keyword: six sigmas; pharmaceutical products; shelf life; stability studies; quality improvements
DOI: https://doi.org/10.31838/ijpr/2020.12.04.191
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