Les "trials" analyses sur la sellette...

Dans cette récente mise en demeure, la FDA pointe du doigt les injections "non officielles" dans un système de données chromatographiques :
1.  Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards (21 CFR 211.194(a)).  
For example, our investigators identified your practice of performing “trial” sample analysis for high performance liquid chromatography (HPLC) analyses at your Chikalthana and Waluj facilities prior to acquiring the “official” analytical data for release and stability testing...In addition, our investigator discovered that some of the “trial” injection data was not kept on the HPLC hard drives because your firm deleted it. Your firm’s management confirmed that the files were deleted as part of an internal audit conducted as a result of the March 2013 FDA inspection at your nearby Wockhardt Limited facility located in Waluj (FEI: 3005289335). The lack of reliability and accuracy of data generated by your firm's laboratory is a serious CGMP deficiency that raises concerns about the integrity of all data generated by your firm. We are also concerned that your quality unit allowed the practices of “trial” injections (about (b)(4) “trial” injections) and deletion of HPLC files to persist without implementation of sufficient controls to prevent data manipulation.

Ainsi que la gestion informatisée de ces données :

2.    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)).
 The inspection documented that all of your QC laboratory computerized instruments ((b)(4) HPLCs) were found to be stand-alone, and laboratory personnel demonstrated that they can delete electronic raw data files from the local hard drive. Your firm deleted multiple HPLC data files acquired in 2013 allegedly to clear up hard drive space without creating back-ups. Your QC management confirmed that there is no audit trail or other traceability in the operating system to document the deletion activity. Furthermore, your analysts do not have unique user names and passwords for the computer and laboratory information systems; your QC analysts use a single shared user identifier and password to access and manipulate multiple stand-alone systems... The (b)(4) HPLC systems in operation at the Waluj facility are also stand-alone, and during our inspection, an employee demonstrated to the investigator that data can be deleted through the local hard drive of the data acquisition system. As with the Chikalthana facility, all Waluj facility employees use a shared password to access the operating system. During the inspection, your firm’s management informed our investigator that (b)(4) back-ups of data are performed. However, we are concerned that your system and procedures permit deletion of HPLC files and that (b)(4) backed up data may not represent all the original data generated.  You are responsible not only for having controls to prevent alteration or loss of the data, but also for recording any changes made to existing data, which should include the date of change, identity of the person who made the change, and an explanation or reason for the change.

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