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Impact of Warning Letters on Indian and United States Based Pharmaceutical Industries: Cause and Effect Analysis
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| Author:
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MEGHANA JIJI JOHNSON, DR RAJU KAMARAJ
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| Abstract:
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Purpose: To identify the cause and effect of warning letters on Indian and United States based companies. For
most of the firms, increase in warning letters is a matter of concern. This analysis will allow other
organizations to recognize repeated findings and learn how to avoid such non-compliance.
Methods: 109 warning letters were issued to the manufacturers in the year of 2018, 2019, and 2020 under
office of manufacturing quality letters, from which 35 warning letters released to Indian and American
companies were reviewed. Pareto analysis performed to determine the top 4 categories. Further review and
Pareto analysis identified the cause of the observations under these categories.
Results: While reviewing, a total of 365 observations were noticed in 35 warning letters, issued due to
significant violation of current good manufacturing practices for finished pharmaceuticals or active
pharmaceutical ingredients. Pareto analysis revealed that the top four issues were 87.95% of the total
observations. These are related to poor quality system (40.27%, 147), poor production control (21.92%, 80),
poor laboratory control (14.8%, 54), breach of data integrity (10.96%, 28). Hence, it is evident that in the past
three years Indian and US companies received warning letters majorly due to poor quality system.
Conclusion: This Analysis shows that the firms have to enhance the quality system, especially the corrective
and preventive action management, adequate quality unit and investigation system. Thus, suggesting that the
manufacturers should study these warning letters periodically to be vigilant and to introduce preventive
measures for avoiding the incident within their company.
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| Keyword:
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Warning letter, Food and Drug Administration, Pareto Analysis, Import alert
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| EOI:
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| DOI:
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https://doi.org/10.31838/ijpr/2021.13.02.341
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| Download:
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Request For Article
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