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KMID : 1142220220170010019
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Regulatory Research on Food, Drug & Cosmetic
2022 Volume.17 No. 1 p.19 ~ p.26
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Analysis of Types of Data Integrity Violations in Good Manufacturing Practice
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Lim Chan-Pyo
Lee Sang-Won
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Abstract
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In order to analyze the types of data integrity violation in Good Manufacturing Practice, this study analyzed 387 warning letters issued by the US FDA during the cGMP inspection of Active Pharmaceutical Ingredient and Finished Pharmaceuticals for a total of 5 years from 2016 to 2020. Type analysis was conducted based on the ALCOA+ principle, and among them, warning letters containing one or more cases of violation of the ALCOA+ principle were 30 cases in 2016, 39 cases in 2017, 32 cases in 2018, 39 cases in 2019, and 21 cases in 2020. There were 161 cases. This means that data integrity violations were confirmed in 42% of the total 387 cases. As a result of type analysis by ALCOA+ principle for 161 warning letters including data integrity violation cases, 71 cases (21%) of complete type violation showed the highest rate. 64 (19%) violations of the Original type, 63 (19%) of the Enduring type violations, 58 (17%) of the Accurate type violations, 35 (10%) of the Available type violations, 22 violations of the Contemporaneous type. (7%), there were 17 (5%) Attributable type violations, 3 (1%) Legible type violations, and 1 Consistent type violation (less than 1%). Through type analysis of data integrity violation cases, it was confirmed that all components of data integrity are linked and that when a defect occurs in one element, violations occur in a chain. The violations involving the highest risk were improper management of computerized systems. Additional in a chain violations occurred because adequate controls were not in place to prevent unauthorized access or alteration of data and to prevent data manipulation and omission. Data integrity is a consideration throughout the pharmaceutical lifecycle. If data integrity is not guaranteed, it will be difficult to guarantee the quality of drugs, and not only will the reliability of pharmaceutical companies decline, but also the foundation of the industry will be shaken, so thorough prevention is necessary
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KEYWORD
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Data integrity, cGMP, Warning letter, ALCOA
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FullTexts / Linksout information
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Listed journal information
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