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Affichage des articles du mai, 2016

La FDA publie un guide sur l'utilisation des enregistrements électroniques de santé dans les études cliniques

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Ce texte reprend les principales définitions et "Bonnes Pratiques" mentionnées dans le guide sur la "Data Integrity" publié récemment.

Plus d'information ici.

Ce fabricant d'API indien sanctionné par la FDA...

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Ce fabricant indien s'est vu mentionner dans sa "warning letter" plusieurs manquements à la "data integrity" :
2.     Failure to review and investigate all production deviations.Our investigator found a torn page from a batch production record for lot (b)(4) of API (b)(4) in the trash. He noted discrepancies between the discarded page and the complete batch production record that your firm represented as the official record for that lot. Your firm did not investigate this deviation or the unacceptable practice of discarding a manufacturing record. You did not determine the root cause or assess its effect on drug quality prior to releasing lot (b)(4)...In response to this letter, provide the following:
a summary of your retrospective investigation of the duplicate batch production records for lot (b)(4) a retrospective review of all batch production records for lots within expiry, including an evaluation of the effect of any discrepancies on API batch qualityyour …