Les enregistrements de laboratoire au coeur d'une Warning Letter récente de la FDA.
Une Warning Letter récente met en évidence deux points clés de la gestion des enregistrements de laboratoire (probablement généralisable à tout enregistrement de lot ou "batch record") :
Nos prestations en matière de conformité réglementaire des enregistrements électroniques (EU, FDA).
- L'intégrité et l'auditabilité de l'édition des enregistrements papiers à partir d'un système informatisé (qui n'est pas sans rappeler le "Barr Case" du début des années 1990) :
1. Your firm has not established appropriate controls designed to assure that laboratory records include all data secured in the course of each test, including graphs, charts, and spectra from laboratory instrumentation, properly identified to show the specific component, drug product container, closure, in-process material, or drug product, and lot tested [21 CFR 211.194 (a)(4)].
Specifically, the inspection revealed that your firm has not established written procedures to control and account for electronically generated worksheets used by analysts to record analytical test results. Analysts in your QC laboratory print an uncontrolled number of worksheets from computers throughout the QC laboratory without supervision.
- La nécessité de maîtriser l'utilisation des feuilles MS Excel au laboratoire:
5. Your firm has not established and documented the accuracy, reliability and performance of your computer systems employed in the release of drug products [21 C.F.R. 211.68 (a)]
For example, your firm did not verify the accuracy of Excel spreadsheets used to calculate product assay analytical results, for all products manufactured for the US market, in order to verify the accuracy of the results obtained.
For example, your firm did not verify the accuracy of Excel spreadsheets used to calculate product assay analytical results, for all products manufactured for the US market, in order to verify the accuracy of the results obtained.
Pour en savoir plus:
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm311326.htmNos prestations en matière de conformité réglementaire des enregistrements électroniques (EU, FDA).
