Biological service - ISS (EN)
Responsible: Dr. Laura Nicolini
phone: (+39) 06 4990 2566
The Biological Service (SB) is focused on the achievement of two objectives, whose main objective is the protection of public health against the biological risk associated with the presence of microorganisms. The first of the two actions is a guarantee to citizen of the quality of medicines and sterile medical devices on the market; the second is supporting basic research projects and collaborations with the Italian National Institute of Health (ISS) and external bodies using the cultivation of both wild type and genetically modified microorganisms (MOGM, link to the Italian website) obtained in a pilot plant originating from the first penicillin production plant.
In carrying out its institutional activity, the SB mainly carries out analytical checks aimed at protecting public health by carrying out the sterility test and verifying the presence of endotoxins and pyrogenic substances in sterile injectable drugs and medical devices. For these analytical control activities, the ISS, through the laboratories of the Biological Service and those of the National Center for the Control and Evaluation of Medicines (CNCF), is part of the international network of Official Medicines Control Laboratories Network (OMCLs) coordinated by the European Directorate for the Quality of Medicines & Healtcare (EDQM).
In particular, the SB carries out the Sterility Test, as indicated in the European Pharmacopoeia, in a sterile area (clean room) classified according to the requirements set by the standards called Good Manufacturing Practices (GMP) and in accordance with the provisions of the international standard UNI / EN / ISO / IEC 17025 "General requirements for the competence of testing and calibration laboratories" provided for test laboratories. Membership in the OMCL Network provides periodic inspections by the EDQM to guarantee the implementation and maintenance of a certified quality system and allows the ISS to participate, as an analytical facility of the Italian Medicines Agency (AIFA), the Canada-Europe Mutual Recognition Agreements (MRA) for the evaluation and control of drugs and for inspections at production sites.
Since the ISS is the Official laboratory for the control of Italian medicines, the SB together with the CNCF - each for their own analytical skills - also carries out Post Marketing Surveillance activities by participating in the drafting of the AIFA Annual Control Program (PCA) which oversees the advisory opinion of the two structures. For its implementation, the PCA provides that batches of sterile injectable medicines are collected on the national territory by the Carabinieri antisofistication and health units (NAS, link to the Italian website) and sent to the ISS for analytical checks; this check is also performed on medicines that have shown quality defects or have shown adverse reactions. The SB carries out analytical control activities also for the notified body of the ISS.
The SB is not divided into departments or functional units, but the staff represents the ISS, according to their skills, in inspection activities on behalf of AIFA (link to the Italian website), as well as in the work of the Expert Groups in charge of the elaboration of monographs of the European Pharmacopoeia, in the work of the Technical Health Committee, and section G of the Ministry of Health which evaluates and authorizes the biotechnological plants and operations involving the confined use of MOGM (Legislative Decree 206/01, link to the Italian website). The SB also ollaborates with the Ministry of Foreign Affairs and international cooperation for the exchange of information provided for in the Convention on the ban on biological weapons, adheres to ISS and INAIL projects for the training of high school and university students and collaborates for the aspects relating to the assessment of exposure to biohazard with the Prevention and Protection Service ISS.