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A Review and Analysis of Data Integrity: Pharmaceutical Industry Perspective
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| Author:
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SUMUKHA P, HEMANTH KUMAR S, GANGADHARAPPA H V
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| Abstract:
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Consistency, accuracy and completeness of data documentation and storage is termed as Data Integrity. It is one of the most fundamental and important requirements in the pharmaceutical industry. Data should follow the ALCOA principles, that is, they should be attributable, legible, contemporaneous, original and accurate. Owing to increase in cGMP violations involving data integrity during quality and regulatory inspections, many warning letters and import alerts are issued by regulators against the products and companies. Data integrity issues have caused major headaches to many pharmaceutical giants. As a consequence, the management of the organizations should take data integrity issues seriously and work on how to deal with them to circumvent destructive ramifications to business, reputation, trust, market value and many other things by getting warning letters or non-compliance reports issued from the regulatory agencies.
The current study focuses on various cases from warning letters issued to pharmaceutical companies in China, India and the United States of America and their analysis of data integrity issues along with possible corrective and preventive actions.
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| Keyword:
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Data Integrity, cGMP Violations, ALCOA, Warning Letter.
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| EOI:
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| DOI:
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https://doi.org/10.31838/ijpr/2020.12.01.068
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| Download:
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Request For Article
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