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Des manipulations sur des enregistrements électroniques et papiers révélés dans cette mise en demeure : 4. Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(b)). For example, you analyzed  (b)(4)  API lot  (b)(4)  on February 14, 2011, at 2:55 a.m., and then retested it at 2:05 p.m. using a new sample solution.  You did not maintain any raw data associated with the initial test. In your response, you stated that the retest was performed due to data deletion of the original analysis.  You concluded that the analyst misused the administrator password to delete and overwrite the actual data logged in the audit trai l. The ability of your analysts to alter and delete electronic analytical data raises serious concerns regarding laboratory controls in place at your facility. ...

Le 28 mai, la FDA a émis le projet de directives, «Accords de fabrication sous contrat pour les médicaments : Accords de qualité» Selon un communiqué de la FDA, la directive a pour objectif de «décrire comment les parties impliquées dans la fabrication sous contrat de médicaments peuvent utiliser les accords de qualité pour définir leurs responsabilités et assurer la qualité, l'innocuité et l'efficacité du médicament". Le guide souligne qu'un accord sur la qualité n'est pas un substitut pour la conformité avec les exigences des cGMP par les deux parties et que le propriétaire du médicament est responsable des actions de son sous-traitant en matière d'assurance de qualité du médicament. Vous pouvez télécharger le guide ici . Ce projet est ouvert aux commentaires ; pour les modalités, cliquer ici .

Dans cette "warning letter" adressée à une société fabricante de dispositifs médicaux, un écart porte sur la minimisation d'un risque de surdosage sans justification argumentée :  3.    Failure to establish and maintain adequate procedures for validating the device design, including risk analysis, as required by 21 CFR 820.30(g).  For example, your risk assessment , # (b)(4) , dated February 4, 2013, for “GemStar Backward Motor Movement Issue for Overdose” is inadequate in that the risk level was calculated to be Acceptable with Justification (AWJ); however, the risk assessment does not document the reasons why the risk level is AWJ when the risk assessment indicates that there are no design risk control measures in place that mitigate the hazard of overdosing.    We have reviewed your response and have determined that it is inadequate because your response does not include rationale as to why the risk analysis was determined to be Acceptabl...

3.    Your firm failed to establish and follow adequate written procedures for the preparation of master production and control records designed to assure uniformity from batch to batch (21 CFR 211.186(a).  For example, the master production records for your  (b)(4)  and  (b)(4)   do not include either the batch size or the weight or measure of each component.  Your response to this observation indicates that you will revise the master production records; however, you have not identified what changes will be included in the revised master batch records. In your response, provide copies of your revised master production and control records. If the changes made to your master production records require revalidation, please include an action plan for completing the validation as well as a copy of the validation protocol.  Plus d'information ici . 

Cette ligne directrice expose les recommandations d'utilisation du standard GS1/2D Data Matrix. Elle est disponible sur le site de l'EFPIA . 

Dans une récente mise en demeure , la FDA a mentionné plusieurs écarts entre la gestion informatisée et le statut ou la localisation physique des stocks : 5.      Failure of distribution and receipt procedures to include a system by which the distribution or receipt of each unit can be readily determined to facilitate its recall. [21 CFR 606.165(a)]. For example, (a)    A query of your firm’s computer system for expired products which are not in quarantine and not previously shipped, identified seven units of Red Blood Cells, Fresh Frozen Plasma or Platelet pools. Your firm cannot determine if the units have been transfused or distributed since they are electronically still in inventory but cannot be physically located. (b)   Your firm identified instances where a final disposition could not be determined. Your firm calls these “discrepant discard” for tracking purposes, though the term “discard...

Une mise en demeure récente mets à nouveau l'accent sur la constitution des Master batch record et l'approbation des changements par la Quality Unit : 5. Your firm failed to follow written procedure for the preparation of master production and control records designed to assure uniformity from batch to batch (21 CFR 211.186(a)). For example, employees made handwritten changes to pre-printed information on Batch Production Control Records (BPCR) in order to describe drugs being packaged. However, your quality unit did not review or approve the corrections, nor did your firm revise the Master Production Control Record (MPCR) . These handwritten changes resulted in packaging errors.