The Food and Drug Administration (FDA) has always stressed the importance of data integrity as part of Good Manufacturing Practice.
Despite that, FDA warning letters issued each year continue to cite it as one of the failures. While the number of citations decreased in the period 2017-2019, it has witnessed an upward surge yet again in recent years.
Although the recent 483s citing data integrity have not reached the figures of close to 80% as witnessed in FY2016, it continues to be a problem that the FDA-governed industry continues to struggle with. Moreover, the deficiencies continue to be the same as they were a decade ago.
It is important to note that FDA has not made any changes to the definitions or regulations or expectations in recent years. There have not been any new guidelines or regulations in the category. This clearly indicates that it is the companies who have not been able to implement the requirements satisfactorily. Read more...
Source Link:- https://www.pharmision.barcodeindia.com/blogs/why-data-integrity-is-important-for-fda-regulated-companies/
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