COETIC votre partenaire pour la gestion et la validation de vos projets réglementés GxP

La FDA a adressé une mise en demeure à un fabricant de principe actif pour des manquements répétés à "l'intégrité des données" chromatographiques : 1. Failure to maintain complete and accurate laboratory test data generated in the course of establishing compliance of your APIs to established specifications and standards. a. There was no written explanation for deletion events observed on audit trails for your standalone HPLC units. Your standard operating procedures (SOPs) did not include instructions for the retention of electronic raw data. In response to this letter, provide your procedures describing requirements to maintain complete data. b. Your laboratory test data did not include records of the integration parameters used for any HPLC analyses. c. There was incomplete raw data to support the test method validation/verification activities for the test methods used for your APIs.  Your response should include new test method validation/verificati...

Dans la gestion des données : 2.       Failure to maintain complete data derived from all laboratory tests conducted to ensure compliance with established specifications and standards.   Your firm failed to prevent raw data from being deleted from the Atomic Absorption Spectrophotometer (AAS) used for elemental analysis testing. Specifically, our investigation found laboratory analysts had access to delete and overwrite AAS raw data. This instrument did not have sufficient controls to prevent unauthorized access to, changes to, or omission of data files and folders. This is especially concerning because our inspection uncovered only 38 raw data files on the hard drive of the AAS, while analysts stated that the AAS had been used for over 400 analyses.  Your firm failed to store the raw data elsewhere . Therefore, all AAS testing results for which no raw data exists are in doubt. Your firm’s improper control over the labo...

La liste ci-dessous résume les récentes injonctions de l'agence américaine en matière de "data integrity": Hospira , Mar 2013, Data Integrity Puget Sound Blood Center and Program , April 2013, Lack of I/O Verification (Data Accuracy) RPG Life Sciences Limited , May 2013, The computer system being used for HPLC did not have adequate controls to prevent unrecorded changes to data. Fresenius , Jul 2013, Unacceptable practices in the management of electronic data. Agila Specialist Private Limited , September 2013, The computer system being used for HPLC did not have adequate controls to prevent unrecorded changes to data. Wockhardt Limited , Dec 2013, The computer system being used for HPLC did not have adequate controls to prevent unrecorded changes to data. Ranbaxy Laboratories , Inc., Jan 2014, The computer system being used for HPLC did not have adequate controls to prevent unrecorded changes to data. USV Limited , Feb 2014, The computer system being used for quality ...