Data integrity is the common issue that is found during the FDA inspections. When FDA finds any invalid or unreliable data during the inspection, it is considered by FDA that the quality of the products manufactured in such a manufacturing facility cannot be good. FDA issues warning letter when the violation of 21 CFR part 11 is found during the inspection.
1. Data Manipulation: Alteration or manipulation of original data to obtain the passing results for any manufactured product is very common issue found in quality control laboratories. The analyst may use fluid or whitener to hide the original results. These methods of correction are against the GMP and GDP regulations.
2. Multiple Sample Runs: During the HPLC and GC analysis any sample is run multiple times to get the passing results. Some analysts delete the data files of these multiple runs. This issue is found in many Indian pharmaceutical companies.
3. Back Dated Documentation: Generally back dating is done in stability analysis. Samples are run on HPLC in backdate by changing date in computer system because of various regions such as unavailability of the HPLC system or manpower. Back dating is considered as a serious issue by FDA.
4 Unauthorized Data Access: Deletion or alteration of electronic data generated by different instruments by the analyst is unauthorized data access. All instruments generating electronic data must be audit trail enabled. Electronic raw data of all analyzed samples must be archived and available on demand.
5. Logbook Recording: When any activity is done on any instrument and it is not recorded in the instrument logbook or timing mismatch on different instruments such as balance and HPLC logbooks. FDA considers that activity is not done actually and fake report is prepared.
6. Data Copying: When any activity or analysis is not done and the data or results of the previous batch are filled instead of the actual analysis. Some analysts do it very fairly by coping electronic data file of the previous batch, rename it with the new batch number and use this data calculating the results for the new batch.
Related: How to plan for a GMP audit?
Related: How to plan for a GMP audit?
Analysts should not do above mistakes during the recording and reporting the analysis results and the supervisors and reviewers should focus on these data integrity issues during their supervision and review of documents. Most of the data integrity issues found during FDA inspections are related to the HPLC analysis and its documentation, therefore, it should be reviewed carefully.
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very good article. Thank you
ReplyDeleteImportant information particularly to those manufacturers which are exporting drugs
ReplyDeleteNot only exporting drug, this sort of practices need to be habit as work culture and rather than blaming Chemist only, company needs to assess their own system and work culture. Such sort of deficiency revealation by regulatory authorities developing bad repuation of Indian Companies. Indian Pharmaceutical companies need to give serious thought into it.
ReplyDelete