The US Food and Drug Administration (FDA) has recently issued a Warning Letter showing the Agency’s focus on data integrity.
This warning letter to an India-based pharmaceutical company contains GMP observations in four areas:
- Incomplete data in laboratory records
- Inappropriate controls over computer systems
- Inadequate written procedures for production and process controls
- Failure to follow certain written procedures
In the description of the observations, data integrity deficiencies are repeatedly highlighted, and the conclusion states that the quality systems do not adequately ensure the accuracy and integrity of the data generated by the company to support the safety, effectiveness, and quality of the drug products it manufactures.
It is also noted that the FDA clearly proposes some necessary actions and asks for appropriate corrective and preventive actions (CAPA). Although unusual, this suggests a trend in the Agency’s warning letters:
- A “comprehensive investigation into the extent of the inaccuracies in data records and reporting”, including “interviews of current and former employees … by a qualified third party”;
- A “current risk assessment of the potential effects of the observed failures on the quality of your drugs”, including the risk to patients;
- A “management strategy for your firm that includes the details of your global corrective action and preventive action plan”, including “measures describing the actions you have taken or will take to protect patients and to ensure the quality of your drugs, such as notifying your customers, recalling product, conducting additional testing, … drug application actions, and enhanced complaint monitoring.”
The reason for this might be connected with the Agency’s concern about the company’s first response. The proposed actions of the company were “insufficient to correct the broad data manipulation and deletion problems observed at your facility and to prevent their recurrence.” The FDA further requests that the response clearly demonstrate “an assessment of the effectiveness of these newly implemented system controls”.
Source: GMP Compliance news