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About us

Mission

The mission of the National Center for Immunobiologicals Research and Evaluation (CRIVIB), founded by the board of the Istituto Superiore di Sanità on 17 July 2007, is to ensure the quality and safety of biological products for human use, with the exclusion of some blood products, for the protection of public health. CRIVIB is divided in four Units, one Administrative Secretariat and one Quality Assurance group.

The CRIVIB activities include the evaluation and control of immunobiological products (vaccines, human immunoglobulins and biotech products) in cooperation with both National (AIFA) and International (European Medicines Agency, EDQM and WHO) bodies. The research activity of CRIVIB is aimed to the quality and safety of this kind of products.

Currently, the Center coordinates within the Istituto Superiore di Sanità the GMP inspection activity to the manufacturing sites, in the context o fan agreemet with the Italian Medicines Agency (AIFA).


Specifically, the CRIVIB activities include the following:

• Official Control Authority Batch Release (OCABR) activity for vaccines and human immunoglobulins and plasma pool testing activity, according to the Italian and European legislation and the OMCL Network guidelines
• Post-marketing surveillance of biological/biotech products, in the context of National and European programmes (CAP and MRP)
• Pharmacovigilance activity on vaccines, human immunoglobulins and other immunobiologicals
• Quality and safety assessment of Marketing Authorisation dossiers for biological/biotech products for human use in the context of National, Centralilised, Decentralices and Mutual Recognition Procedures
• Research activity concerning the control and standardization of biological/biotech products for human use manufactured by classical and innovative processes, focusing on methods or models to be applied for evaluating quality, safety and efficacy
• Participation in and coordination of national and international collaborative studies aimed at the standardization of methods and reference preparations
• Participation in Proficiency Testing Studies (PTS) and organization of External Quality Assessment studies
• Management of databases on control, research and surveillance activities of the Center
• Participation in the activities promoted by National (AIFA, CCM) and International (EMEA, EDQM " Ph.Eur., OMCL Network- WHO, CDC, EISS) bodies.


The quality of the activities carried out by the CRIVIB is ensured by its Quality Assurance System (SAQ). The accreditation of the CRIVIB is based on external Audits performed by international bodies.

Published 01-02-2010 in About us , last update 10-02-2010

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