Hello good people of the world! Today’s post is about a recent (January 2018) warning letter issued by the FDA to a Japanese cosmetics and drug manufacturing company called Daito Kasei. The warning letter, which can be found here, underscores the need maintain focus on data integrity requirements in our modern age. This warning letter includes explicitly the following data integrity remediation steps:
A. A comprehensive investigation into the extent of the inaccuracies in data records and reporting.
This is saying root cause analysis was not sufficiently performed and the agency is concerned about systemic data integrity issues.
B. A current risk assessment of the potential effects of the observed failures on the quality of your drugs. Your assessment should include analysesof the risks to patients caused by the release of drugs affected by a lapse of data integrity, and risks posed by ongoing operations.
Here the agency highlights their position that data integrity issues can directly affect patient safety.
C. A management strategy for your firm that includes the details of your global corrective action and preventive action plan.
The agency is reiterating that data integrity is of paramount importance.
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