USFDA audit compliance challenges-Data integrity is still a high frequency concern

The common data integrity problems that have been observed by FDA inspectors in past:

Non contemporaneous Recording: Failure to record activities at the time when activity was performed. There is evidence that the records were signed by company personnel when the person was actually absent on that day.

Document back-dating: Backdating stability test results to meet the required commitments.

Copy of existing data as new information: Test results from previous batches were used to substitute testing for another batch or acceptable test results were created without performing the test.

Re-running samples to obtain better results: Multiple analyzes of assay were done with the same sample without adequate justification and in some cases samples were tested unofficially or as a trial analysis until desired test results obtained.

Data fabrication and data discarding: Original raw data and records were altered for e.g., by using of correction fluid or Manipulation of a poorly defined analytical procedure and associated data analysis in order to obtain passing results.

These observations generally lead to issue of warning letter to imposition of import alert in many cases. These concerns may be prevalent in any organization with the knowledge of top management or in rare cases, with no visibility to top management. In any case, as we all understand it is a legal requirement and negligence cannot be an excuse.

Organizations should design their activities of manufacturing built on culture of quality which is essentially top down approach. From development to customer, throughout product path and life cycle, the integrity of product has to be demonstrated in letter and spirit. 

The integrity of data generated by a regulated pharmaceutical companies and laboratories matters most, because properly recorded information is the basis for manufacturers to assure product identity, strength, purity, and safety and non-compliance found in the integrity of data leads warning letters and a regulatory action from the U.S. Food and Drug Administration ( USFDA ).