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

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 Acceptable with Justification

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 .