Acting Director: Dr. Claudia Signoretti
phone: (+39) 06 4990 2549
The Biological Service (BS) directs its activities towards the achievement of two objectives whose main element is the protection of public health against the biological risk related to the presence of microorganisms. The first of the two actions has the objective to guarantee - through a certified analytical control - the quality of injectable medicines and sterile medical devices available on the market; the second action has the objective to conduct research projects, in collaboration with other ISS Structures and external bodies, growing and studying both wild type and genetically modified microorganisms (MOGM) obtained in a pilot plant.
The BS carries out its institutional activity, aimed at the protection of public health, by performing sterility tests and verifying the absence of endotoxins and pyrogenic substances in sterile injectable drugs and medical devices.
The ISS, supported by BS and National Centre for Drug Control and Evaluation (CNCF) analytical control activities, is the Italian Official Medicines Control Laboratory (OMCL-IT_ISS-H) and member of the international network of (OMCLs) coordinated by the European Directorate for the Quality of Medicines & Health Care (EDQM).
Accordingly the BS performs the sterility tests, in compliance with the European Pharmacopoeia monographs, in a clean room classified according to Good Manufacturing Practices (GMP) rules and in accordance with the international standard UNI/EN/ISO/IEC 17025 "General requirements for the competence of testing and calibration laboratories". The application of these international standards requires periodic inspections by EDQM to ensure the implementation and maintenance of a certified quality system and allows ISS to participate, as the analytical facility of the Italian Medicines Agency (AIFA), in the Canada-Europe Mutual Recognition Agreements (MRA) for the evaluation and control of drugs and for GMP inspections of medicine, active pharmaceutical ingredient and medicinal gas production sites.
Since ISS is the Official Italian Laboratory for the Control of Medicinal Products, the BS jointly with the CNCF - each according to their own analytical competences - also carries out Post Marketing Surveillance activities, participating in the drafting of the AIFA Annual Control Program (PCA). In the context of the PCA, sterile injectable drug samples are collected by the NAS Carabinieri on the national territory and sent to the ISS for analytical controls.
Analytical controls are also performed on medicinal samples that have shown quality defects or have given rise to adverse reactions.
The BS carries out analytical control activities also for the ISS Notified Body (ON373).
The BS is not organized into departments or functional units: the personnel, on the basis of their competences, represents the ISS, by participating in AIFA inspection activities and in some working groups: the EDQM Bacterial Endotoxin Test Working Party (BETWG) for the elaboration of European Pharmacopoeia monographs dealing with bacterial endotoxins, and the Ministry of Health Technical Committee, the Italian competent authority that, according to the Italian legislative decree 206/2001, authorizes the contained use of MOGM in biotechnological operations performed in any previously authorized laboratory.
The BS collaborates also with the Ministry of Foreign Affairs and International Cooperation for the exchange of information according to the Biological and Toxin Weapons Convention (BTWC) and adheres to the cooperation agreement into ISS and INAIL finalised to train high school and university students on biotechnological applications. Finally, as regards the aspects relating to the biological risk assessment, the BS collaborates also with the ISS Prevention and Protection Service for both training and information aspects.