Une nouvelle mise en demeure FDA sur des défaillances dans la gestion des enregistrements électroniques de laboratoire


Gulf Pharmaceutical Industries 2/23/12


4. Your firm has not established appropriate controls over computer or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.  Your firm also fails to maintain a backup file of data entered into the computer or related system [21 CFR § 211.68(b)].
For example,
a) There is no system in place to ensure that all electronic raw data from the laboratory is backed up and/or retained.
During the inspection, you informed our investigators that electronic raw data would not exist for most HPLC assays over two years old because data is not backed up and storage space is limited. 
Data is deleted to make space for the most recent test results.  You also informed our investigators that printed copies of HPLC test results are treated as raw data.
Printed copies of HPLC test results from your firm’s systems do not contain all of the analytical metadata (for example: instrument conditions, integration parameters) that is considered part of the raw data.  We acknowledge that your response indicates that you have created a procedure in order to implement the back-up and retention of HPLC data.  This electronic HPLC data supports testing, disposition, and other significant quality control decisions, and it is essential that you maintain this information for each batch.  In your response, please provide a detailed update on your firm’s implementation of this correction.  Also describe your firm’s policy for retaining HPLC raw electronic data associated with pending applications. 
b) You have not implemented security control of laboratory electronic data.  All laboratory analysts share the same password for the HPLCs in the QC analytical chemistry lab and Omnilog in the microbiology lab.  In addition, analysts have access to the HPLCs which allow them to create and/or modify validated methods.
Your response indicates that SOP EDS-084:  Procedure to Assign User Access Levels and Privileges for Computerized Analytical System has been issued and training has been provided.  Please clarify in the response to this letter how you define the levels of authorization or the user access and privileges for analysts.  Your response also explains that analysts now have their own passwords and that changes will be captured by audit trail.  We also note that your SOP does not have provisions for any audit trail reviews to ensure that deletions and/or modifications do not occur.  Please provide an explanation of your firm’s procedures regarding audit trails.
We recommend that you conduct a complete and extensive evaluation of your overall quality and manufacturing controls to ensure that all finished dosage drugs manufactured at your facility meet the quality and purity characteristics they purport to possess.  We highly recommend that you hire a third party auditor, with experience in detecting data integrity problems, who may assist you in evaluating your overall compliance with CGMP.
Pour en savoir plus sur :

La warning letter en question

Nos prestations en matière de conformité réglementaire des enregistrements électroniques (EU, FDA).

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