lundi 23 mai 2016

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

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

Plus d'information ici.

lundi 2 mai 2016

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

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 quality
  • your CAPA plan describing actions and controls to ensure accuracy and retention of all records including original batch production records
  • documentation that your employees are adequately trained to complete batch production records contemporaneously and accurately, to investigate production record discrepancies, and to understand the connection between accurate recordkeeping and product quality
3.     Failure of computerized systems to have sufficient controls to prevent unauthorized access or changes to data. Your firm’s computer system for entering test results and storing certificates of analysis (CoA), which document whether a drug meets specifications, does not have sufficient controls to prevent unauthorized changes to a CoA after quality unit approval. During the inspection, our investigator reviewed (b)(4) CoA stored on computer #16, all of which were approved by the quality unit. A manager demonstrated for our investigator how results on an already finalized CoA could be manipulated after the formal quality unit approval. Also, the quality unit’s electronic signatures on these CoA were uncontrolled images of signatures rather than certificate-based electronic signatures.
Pour plus d'information sur cette "warning letter" ici.



Pour en savoir plus sur la "Data integrity" : la position des autorités réglementaires (MHRA, FDA, OMS), les actions de maîtrise du risque mises en oeuvre par des industriels (LILLY, UCB), nous vous invitons à vous inscrire à la journée A3P SUISSE sur "eCompliance - Data Integrity" le 12 mai prochain à Lausanne.