Batch records are critical records
Une Warning Letter récente met l'accent sur les caractéristiques attendues des Batch records du point de vue de la FDA:
Batch records are critical records and it is your responsibility to ensure that all production and control records are accurate, complete, authentic, and produced concurrently with the documented activity, and that employees are appropriately trained.
Nos prestations en matière de conformité réglementaire des enregistrements électroniques (EU, FDA).
2. Your quality control unit (QCU) failed to review and approve all production and control records to determine compliance with all established, approved written procedures before releasing and distributing a batch [21 C.F.R. § 211.192].
Batch records are critical records and it is your responsibility to ensure that all production and control records are accurate, complete, authentic, and produced concurrently with the documented activity, and that employees are appropriately trained.
Pour en savoir plus:
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm309971.htmNos prestations en matière de conformité réglementaire des enregistrements électroniques (EU, FDA).
