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Un fabricant n'a pas validé des logiciels utilisés dans la production ou le contrôle de ses dispositifs médicaux : 2.    Failure to validate computer software for its intended use according to an established protocol when computers or automated data processing systems are used as part of production or the quality system, as required by 21 CFR 820.70(i). a.    Your firm uses “(b)(4)” and “(b)(4)” to take (b)(4) of patients’ teeth and determine the desired movement pattern to generate your dental aligners. Your firm has not validated this software, you use as part of your production activities, for its intended use. b.    Your firm uses “(b)(4)” and “(b)(4)” to convert (b)(4) of patients’ impressions to file types compatible with the (b)(4) used to manufacture the molds for your dental aligners. You have not validated these software programs for their intended use . Plus d'information ici .

Ce fabricant indien a fait l'objet d'observations sur la "data integrity" dans une récente mise en demeure: 2.  Your firm failed to exercise sufficient controls over computerized systems to prevent unauthorized access or changes to data. a.   Your firm failed to adequately control the use of computerized systems in the quality control laboratory. Our inspection team found that the laboratory manager had the ability to delete data from the Karl Fischer Tiamo software . During our limited review of your Karl Fischer data, we found that one file had been deleted. However, because the audit trail function for the Karl Fischer Tiamo software was not activated , and because eight different analysts share a single username and password , you were unable to demonstrate who performed each operation on this instrument system. You do not have a record of the acquisition of all data, nor do you have records of changes to or modifications of such data. b.   The inspection al...

La US FDA vient de publier une mise en demeure à l'encontre de ce laboratoire indien pour plusieurs manquements dont certains portent sur la maîtrise et la traçabilité des accès aux systèmes automatisés: 5.    Your firm failed to routinely calibrate, inspect, or check according to a written program designed to assure proper performance and to maintain adequate written records of calibration checks and inspections of automatic, mechanical, or electronic equipment, including computers, used in the manufacture, processing, packing, and holding of a drug product (21 C.F.R 211.68(a)). Since 2005, you have been using an un-validated and unqualified Agilent data acquisition un it (DAU) to monitor the temperature of the microbiological incubation rooms for media filled vials. During our inspection, your quality engineer officer and QA manager stated that the DAU has not been qualified, and that you have not used a preventative maintenance schedule for this equipment during the ...

Le 2 décembre 2015, l’ANSM (Agence Nationale de Sécurité du Médicament et des produits de santé) a fait part d’une décision de police sanitaire envers Stallergenes. Cette décision suspend temporairement les activités de production et de distribution de tous ses produits.    Stallergenes procède également au retrait de ses produits  APSI (Allergènes Préparés Spécialement pour un Individu) délivrés depuis le 13 Août 2015. Pour les spécialités pharmaceutiques, la nécessité d’un rappel des produits est en cours d’évaluation. La mise en place d’un nouveau système informatique en cause La décision de suspension temporaire d’activité fait suite à la mise en place d’un nouveau système informatique qui a entrainé des erreurs dans la mise à disposition des produits aux patients (erreur dans la composition, erreur d’étiquetage, erreur dans la délivrance de ces traitements). Cette suspension sera effective jusqu’à remise en conformité du système informatique...

Ce laboratoire allemand qui dispose de deux sites en Inde a été mis en demeure par l'agence américaine notamment sur les écarts suivants : 1.     Your firm failed to prepare batch production and control records for each batch of drug product that include documentation of the accomplishment of each significant step in the manufacture, processing, packing, or holding of the batch (21 CFR 211.188(b)).   On August 28, 2014, FDA investigators identified instances of non-contemporaneous documentation of batch production activities. Two uncontrolled Excel spreadsheets were used to record discrepancies and certain in-process drug quality data . This data was initially missing in the batch manufacturing record.  Your firm later entered this data into batch records and backdated them . 2.     Your firm failed to maintain adequate written records of major equipment maintenance (21 CFR 211.182).   On August 25, 2...

Ce laboratoire indien connu a reçu une mise en demeure sévère de la US FDA dont voici les écarts les plus significatifs en terme de "Data Integrity" : 1.     Failure to maintain complete data derived from all laboratory tests conducted to ensure compliance with established specifications and standards.   Your laboratory records did not contain all raw data generated during each test for API batches manufactured at your firm. The investigator found that batch samples were routinely re-tested following failing or atypical results until acceptable results were obtained, and that failing or atypical results were not investigated or included in the official laboratory control records.    During the inspection, the presence of an uncontrolled “Custom QC laboratory” (CQC) was discovered by our inspection team. The existence of this laboratory was previously unknown to FDA. Your QC Associate Director acknowledged that t...