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Year : 2019  |  Volume : 2  |  Issue : 2  |  Page : 34-39

Rare event control charts in drug recall monitoring and trend analysis of data record: A multidimensional study

Department of Microbiology and Immunology, Cairo University, Cairo, Egypt

Correspondence Address:
Mostafa E Eissa
Independent Ph.D. Researcher, Department of Microbiology and Immunology, Cairo University, Cairo. Tel.:+201006154853.
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/JQSH.JQSH_3_19

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Background: Control of the quality of pharmaceutical and healthcare products in the market is mandatory to ensure the safety and efficacy of the delivered product to the final consumers. The United States Food and Drug Administration (FDA) is providing a continuous and comprehensive updated list for various healthcare issues including drug recalls. Methods: This study provides a multidimensional analysis using statistical process control (SPC) tools to evaluate the risk associated over a 3-year period (2016–2018). Results: The study showed a simple implementation of the combination of SPC tools, which demonstrated that the major contributors to recalls are microbiological quality issues, problems with product compositions, and packaging defects. Months that contributed by more than 60% of the total recalls were from May to August, November, and December. Conclusion: The general trend of drug recall rates is increasing yearly, which should be a warning signal for the regulatory agencies to take preventive measures to control and prevent excessive cases of recalls.

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