Medicines, vaccines and advanced therapies

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Medicines, vaccines and advanced therapies

Official laboratory for the control of medicines for Italy

The Istituto Superiore di Sanità (ISS, the National Institute of Health in Italy) is the Official Medicines Control Laboratory (OMCL) for Italy. Its functions are almost entirely carried out within the ISS National Centre for the Control and Evaluation of Medicine and the Biological Service. The ISS does not operate in an isolated manner but within a European context, where a network of official laboratories for the control of medicines has been established and made operational for the last twenty years, managed by the European Directorate for the Quality of Medicines (EDQM) based in Strasbourg, and operating within the Council of Europe area. The main task of OMCL network is the analytical control of drugs for human and/or veterinary use, carried out in various capacities and at various stages of the process of production, distribution and use of the drug by the citizen, with the aim of increasing the safety margins of the drug itself by checking its quality repeatedly at various levels, including when the drug is already on the market (AIFA annual control program).

The ISS through National Centre for the Control and Evaluation of Medicines fully participates in all European initiatives in the field of laboratory analysis of chemical and biological drugs, with particular emphasis on especially important matters, such as the fight against falsification, the batch-to-batch examination of vaccine or blood products to be placed on the Italian market not previously controlled by another European OMCL, and the analysis of medicines potentially containing defects or which have given rise to suspected adverse events reported by the pharmacovigilance system. This activity is managed in the European context in compliance with precise standards (ISO 17025) to guarantee a homogeneous behavior and result regardless of which OMCL performs the tests, in order to guarantee the mutual recognition of the results generated by an OMCL from another country.

This mutual recognition is supported by the fact that work corresponding to the ISO standards (International Organization for Standardization) is also assessed in the course of third-party audits conducted by teams managed by the EDQM and made up of experts from other European OMCLs . Therefore, during these audits, the OMCL network confirms a mutual trust in the results and conclusions both in relation to the pre-release tests on the market (batch release of vaccines and blood products) and other investigations on products, including those of Community interest. The harmonization of behavior between the various OMCLs is managed both at a cultural and technical level, through the use of shared documents, which cover activities related to both human and veterinary, chemical and biological drugs and through meetings held at various levels and with different frequency.

The ISS performs its function of OMCL both independently and upon request of the Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA) or other authorities, in relation to the various types of problems to be addressed.


Dipartimenti/Centri/Servizi

Centres National Centre for Control and evaluation of medicines Biological service

Target

Citizen Healthcare professional Information specialist

Topics

Medicines, vaccines and advanced therapies

Back L’Assicurazione della Qualità delle Attività Analitiche

Le Attività Analitiche svolte dal CNCF e dal Servizio biologico vengono effettuate obbligatoriamente nell’ambito di un Sistema di Gestione Qualità (SGQ), realizzato in accordo con la normativa tecnica indicata nelle Norme Internazionali e Nazionali ISO, in particolare con la Norma Nazionale UNI/CEI/EN ISO/IEC 17025 prevista per dimostrare la competenza dei Laboratori di Prova e Taratura nel generare risultati validi.

Il rispetto delle succitate norme è condicio sine qua non per consentire l’accettazione dei risultati da parte di tutti gli altri Stati Membri dell’Unione Europea (UE) (Mutuo Riconoscimento da parte dei Paesi dell’UE) o da parte delle altre Autorità che li hanno richiesti.

Il SGQ del CNCF è l’insieme di azioni pianificate e sistematiche atte a garantire che le attività di controllo sui farmaci soddisfino i requisiti di qualità prestabiliti, fornendo così una evidenza esterna obiettiva della qualità del lavoro svolto. Lo scopo del SGQ è quello di mantenere un livello adeguato di Qualità costante nel tempo che si realizza attraverso la verifica dell’applicazione di adeguati Metodi di Prova (Saggi Analitici) opportunamente convalidati, del monitoraggio dei Risultati Fuori Specifica, gestione dei Materiali di Riferimento e del loro monitoraggio statistico attraverso opportune Carte di Controllo, degli Studi Collaborativi e Studi di Valutazione Esterna di Qualità, della gestione adeguata e manutenzione delle Apparecchiature.

Le strutture in ISS, che effettuano Attività Analitica e che sono confluite a formare il CNCF, insieme al BIOL, nel corso degli anni, sono state sottoposte a Visite Ispettive di terza parte effettuate da WHO (World Health Organization – anni 2006,2016), EDQM (European Directorate for the Quality of Medicines & HealthCare- anni 2004, 2008, 2010, 2012, 2016, 2017), EMA (European Medicines Agency-anno 2002), CANADA (2002, 2015 e anni seguenti con frequenza annuale), Giappone (anno 2004), PIC/S ( Pharmaceutical Inspection Co-operation Scheme - anno 2004 al fine di confermare la conformità alla Norma 17025.

Il prossimo Audit è previsto per l’autunno 2020.


Dipartimenti/Centri/Servizi

National Centre for Control and evaluation of medicines Biological service

Target

Citizen Healthcare professional Information specialist

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Document

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Medicines, vaccines and advanced therapies Official laboratory for the control of medicines for Italy