ISSN 0377-9556 (PRINT)
ISSN 2383-9457 (ONLINE)
ISSN 2383-9457 (ONLINE)
Data integrity issues identified in regulatory observations between 2012 and 20171)
| Data Integrity Issues* | Description |
|---|---|
| Failure to perform required testing | Sterility testing of finished product, in-process, active pharmaceutical ingredient (API), environmental monitoring, water, and media fills where the required sampling, incubation, and/or testing were not performed, while records were generated as if the sampling or testing had been performed. |
| Falsification of critical data | Citations have been issued for falsification of sampling information or test result data in worksheets/logbooks/test reports, including fabricated results for samples not attained and/or incubated, and for reporting failing results as passing. |
| Deletion of data | Citations have been issued for deletion or overwriting of electronic data generated in the laboratory. |
| Deficiencies in deviation reports and investigations of data integrity issues | Deficiencies such as inadequate root cause (e.g., did not address data manipulation and falsification), failure to expand the scope of the investigation to assess potential impact of poor data integrity practices on other functional areas. |
| Falsification of CGMP records | Falsification of CGMP records, including modification of records, omissions, or reporting inaccurate results. |
| Failure to configure computerized systems to meet the requirements for the security and control of data | Permitting unauthorized system access, allowing for the deletion of electronic and printed raw data (including information related to undesirable or failing results, and/or audit trails). |
| Failure to document laboratory records contemporaneously and/ or deliberate falsification of manual records | Inconsistencies when comparing laboratory documentation records against the electronic data files (e.g., dates recorded on sample receiving records are inconsistent with the date stamped on the HPLC chromatograms). |
| Performing unreported sample test injections | Trial analyses and deletion of data were found to be closely related; specifically, the deletion of data or the failure to configure systems to detect the deletion of data. |
*These examples are not all-inclusive but are representative of issues uncovered by regulatory agencies during recent inspections.