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

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.

Ce qui suit est un extrait d'une communication de la société RALTUS Software : "You can now control the level of step detail and imagery shown based on Risk and Step type (supporting, proving and non-proving). This allows the level of detail and degree of rigor of the testing script to be tailored to the risk. We have also added the ability to use your own Word docs as the template basis for the outputs produced from execution whether this be in a paper or paperless environment. The benefit of this is that your validated outputs are exactly the same as your SOP's and are therefore consistent right across scripts.  Secondly, we have recently signed a number of customers to use our solution for validating their systems. These include companies such as Sonexus Health, Ranir, Volcano, ASO. We now have case study evidence which demonstrates that customers are reducing their time for script creation by about 40% and the effort to execute scripts by between 45-60% (...

Cette mise en demeure adressée à une société japonaise de production d'API mentionne l'écart suivant : 4.    Failure to prepare adequate batch production records and failure to identify produced batches with a unique batch identification number. Batch Record  (b)(4)  Lot  (b)(4) , reviewed during inspection, was not controlled or reviewed by your firm prior to the release of API for distribution.  Your firm failed to ensure that batch records were completed in their entirety or that they specified the equipment used during API manufacturing .  At least one executed batch record was observed to have no associated lot number.  We also noted that your firm has no written procedure for assigning lot numbers to API products and failed to ensure that lot numbers were unique identifiers .   While firm officials stated that certain unwritten rules are followed in creating batch numbers, application of these rules appeared ...

La société FISIOLINE (dispositifs médicaux) a été notifiée d'un écart par la FDA pour la non validation de son logiciel de SAV : 4.      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).  For example, the software developed by your firm to record, evaluate, investigate, correct and repair incoming technical assistance calls, complaints, and service records was implemented in the first part of October 2012, and has not been validated .  No validation documentation was available for an established protocol, any testing data, or a finished report for the validation of this system. Mr. Lucca Ferrua, the Assistant Manager, indicated that your firm had not validated the software system. Ainsi que des lacunes sur la qualification de conception : 5.   ...