Des nouvelles injonctions sur la "data integrity"...
4. Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(b)).
For example, the computer in your quality unit area did not have controls to restrict access and prevent unauthorized changes to data files and folders. All employees had access to your Annual Product Review (APR) spreadsheet. The desktop computer containing the APR was not locked.
Pour ce fabricant chinois d'API, des nombreux écarts ont été notés :
1. Failure to maintain complete data derived from all laboratory tests conducted to ensure compliance with established specifications and standards.
During the inspection, FDA investigators discovered a lack of basic laboratory controls to prevent changes to your electronically-stored data and paper records. When you encountered suspect and out-of-specification (OOS) results, you retested samples until you obtained desirable results. You did not investigate, review, or report original results. You relied on incomplete records to evaluate the quality of your drugs and to determine whether your drugs conformed to established specifications and standards...
2. Failure to prevent unauthorized access or changes to data, and to provide adequate controls to prevent manipulation and omission of data.
During the inspection, we observed that your laboratory systems lacked access controls to prevent deletions or alterations to raw data. For example, our investigator reviewed the electronic folder containing data files generated when your firm tested (b)(4) batches of (b)(4) API for residual solvents by gas chromatography (GC). The investigator compared the file names in the folder with the metadata generated by the Chemstation software you used to operate your GC system, and found that two chromatograms had been deleted from the system. Because there were no controls restricting operators’ or supervisors’ abilities to alter or manipulate the data, an analyst had completed two runs and deleted the results, and then changed the subsequent file names in the folder where reported data was stored to make it appear that the deleted runs never occurred...
3. Failure to record activities at the time they are performed.
During the inspection, we observed that you did not have worksheets for recording microbial test results and that you failed to contemporaneously document microbial limits test results for (b)(4) API batch (b)(4)....
Enfin le délai de production des enregistrements a également fait l'objet d'une observation:
Delay producing records during inspection
Some records that our investigators requested during the inspection were not available for review.
For example, during the inspection of the microbiology laboratory, our investigators requested the completed microbial QC worksheet for (b)(4) API batch (b)(4). Your laboratory staff led our investigators out of the lab to another room where, according to your staff, the completed document was located. After approximately 30 minutes outside of the laboratory without being provided the completed worksheet, our investigators reentered the microbiology lab and observed a microbiologist with a partially-completed QC worksheet for the batch in question.
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