lundi 27 mai 2013

Une mise en demeure de la FDA pointe une mauvaise appréciation du risque...

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 when your firm had no measures in place to mitigate the risk which has the potential for patient overdose.

Cette remarque rejoint celle du guide PIC/S PI011 (14.3) :

The risk analyses and the results, together with reasoning for critical or non-critical classifications, should be documented. Risks potentially impacting on GxP compliance should be clearly identified.

Plus d'information ici.

lundi 13 mai 2013

Une nouvelle "Warning Letter" pointe du doigt la gestion des "Master Batch Record"

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

mercredi 1 mai 2013