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In 2015, as part of the Pharmaceutical CGMPs for the 21st Century Initiative, FDA sought input from industry on the establishment of an FDA Quality Metrics Program as another mechanism to promote continual improvement in manufacturing quality. Metric is a word we will often meet and therefore it is worth spending on some words. Vuoi rimanere aggiornato sui nostri post educativi, seguici su Linkedin basta andare https://lnkd.in/d86jcAb e +Segui or +Follow

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AUDIT DA REMOTO. In luglio abbiamo discusso e scambiato esperienze tra gli Associati in merito alla conduzione di Audit fornitori in remoto. Approfondito l’argomento inerente l’idonea valutazione del rischio a garanzia rispetto GMP e scaturiti molteplici suggerimenti operativi e pratici per una corretta organizzazione ed esecuzione. Data l’emergenza globale causata dal COVID-19, diverse Autorità Regolatorie in tutto il mondo si sono attivate per gestire la crisi e la possibilità di implementare misure risk-based per garantire il mantenimento di un monitoraggio efficace dell’applicazione delle #GMP e quindi della qualità dei prodotti medicinali.

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Il parallelo fra DQ e IQ: parametri critici e criteri di accettazione Nel capitolo dedicato alla DQ si è precisato quali sono i documenti di ingegneria che sono oggetto di qualificazione . Si è altresì evidenziato che la fase di individuazione delle criticità (in ogni senso: in termini di produttività, di qualità, di sicurezza) è la progettazione, e che in fase di DQ, sulla scorta dei “desiderata” definiti nelle URS, si verifica che tali criticità siano state adeguatamente comprese in tale progettazione

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Il capitolo secondo si propone l’obiettivo di illustrare brevemente la documentazione tecnica che deve essere oggetto di design qualification (approvazione dell’ ingegneria di base). Un breve cenno verrà fatto alle modalità generalmente seguite per lo sviluppo e l’aggiornamento di tale documentazione (da “prima emissione“ a “emesso per approvazione“ per finire a “as built”), precisando che ogni modifica successiva alla emissione per approvazione (ciò che è la “designi qualification”) dovrà essere gestito attraverso una prassi/procedura di change control. Infine si tratterà in merito alla corretta gestione del rapporto con i fornitori, sia di apparecchiature/macchine che di servizi di montaggio, premessa indispensabile a una corretta e soddisfacente attività di pre-commissioning and commissioning e, in definitiva, di IQ/OQ.

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Negli ultimi anni, attraverso interpretazioni di linee guida della Food & Drug Administration e dell’ ICH, nonché lo studio di lavori apparsi in specifiche pubblicazioni o presentati in conferenze e seminari, il tema della Qualifica degli impianti ha, via via, ricoperto un importante aspetto nell’ implementazione della qualità dei prodotti farmaceutici in tutto il loro complesso ciclo produttivo

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REGULATORY TECHNICAL WRITING Buone pratiche, suggerimenti operativi, esempi pratici che si terrà giovedì 21 maggio dalle 9.30 alle 13.00 Nel contesto attuale in cui svariate attività sono condotte in remoto, la qualità e la chiarezza della reportistica tecnica prodotta è un fattore ancora più cruciale per garantire adeguata comunicazione, conformità alle procedure GMP e degli Enti regolatori

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