Quality Assurance (QA) Department
It conducts all systematically organized activities based on Good Manufacturing Practice (GMP) guidelines, as well as the requirements of ISO 9001, ISO 13485, ISO 22000, ISO 14001 standards, and other standards established at the Torlak Institute, aiming to ensure that the products meet the prescribed quality required for their intended use.
Head of Medical Services
Within the Quality Assurance (QA) Service, organizational units are organized as follows:
- Department for Documentation, Internal Audits, and Training,
- Department for Validations and Qualifications,
- Department for Regulatory Affairs and Pharmacovigilance.
Quality Control Department (QC)
It deals with sampling, specification development, testing, as well as organizing, documentation, and approval procedures ensuring the necessary testing is conducted and preventing raw materials needed for production and finished products from being released for sale or delivery before their quality is assessed as appropriate.
Head of Medical Services:
Within the Quality Control (QC) Service, organizational units are organized as follows:
- Department for Virological Control,
- Department for Bacteriological Control,
- Department for Environmental Monitoring,
- Department for Chemical Control.
Department of Bacteriological Production
It deals with the production of bacterial vaccines, serums, immunodiagnostic agents, allergens, and lactopreparations. The scope of work of the Bacteriological Production Service is very diverse and includes work with anaerobic and aerobic bacteria (Clostridium tetani, Corynebacterium diphtheria, Bordetella pertussis, Mycobacterium bovis BCG, Lactobacillus rhamnosus, etc.), serums, and allergenic sources.
Head of Medical Services:
Within the Bacteriological Production Service, organizational units are organized as follows:
- Department for Active Pharmaceutical Ingredients (API) Production,
- Department for Immunochemistry,
- Department for BCG Vaccine Production,
- Department for Lactopreparation Production,
- Department for Combination and Finalization,
- Department for Serums and Laboratory Animals,
- Department for Allergen Production,
- Department for Lyophilization and Central Sterilization.
Department for Viral Production
It deals with the production of the active component of the influenza vaccine (monovalent combined harvest) and the production of media and solutions, as well as the production of ready-made substrates for the needs of the Influenza Vaccine Production Department and other organizational units of the Institute, as well as for commercial purposes.
Within the Viral Production Service, the following organizational units are organized:
- Department for Media and Solutions,
- Department for Influenza Vaccine Production.
Department for Production of Diagnostic Supplies
It engages in production activities including: processing of biological raw materials, manufacturing liquid protein hydrolysates and extracts, production of powdered peptones and extracts, manufacturing ingredients used in the composition of microbiological media, production of dry microbiological media, manufacturing of defibrinated sheep blood, production of diagnostic tablets, selective supplements, and other products for microbiological diagnostics.
Head of Medical Services:
Within the Diagnostic Reagents Production Department, the following organizational units are structured:
- Section for Bacteriological Media
- Section for Diagnostic Products
Laboratory Diagnostics Department
It deals with the diagnosis of human diseases caused by viruses and bacteria, as well as allergological and immunological testing. It participates in virological surveillance of infectious diseases of public health significance and clinical trials of viral vaccines.
Head of Medical Services:
У оквиру Службе за лабораторијску дијагностику организују се уже организационе јединице:
- Department for Serodiagnostics and Molecular Diagnostics
- Department for Bacteriology and Immunology
- Department for Cell Cultures
- Department for Clinical Trials
Service for Legal and Economic-Financial Affairs
The Service for Legal and Economic-Financial Affairs performs all systematically organized business administrative activities in the field of legal and economic operations to carry out administrative tasks according to pre-established business goals and business strategies of the Institute’s Management Body, respecting positive regulations and good business practices. By aligning the business activities of organizational units within the Service, it ensures the smooth operation of the Institute’s commercial activities, whose business changes and economic events are recorded through program databases, enabling analysis, control, and reporting of business events, as well as assessing future business trends through planning and analytical activities.
Head of Non-Medical Services: Gordana Vićentijević
Within the Department for Legal and Economic-Financial Affairs, the following organizational units are organized:
- Department for General Legal Affairs and Public Procurement,
- Department for Planning, Analysis, Control, and Reporting,
- Department for Finance and Accounting,
- Department for Commercial Affairs.
Service for Technical and Related Tasks
The Technical and Related Services Department performs the tasks of ongoing, preventive, and corrective maintenance of systems, equipment, and facilities within the Institute in accordance with Standard Operating Procedures (SOPs) and applicable regulations.
Manager of Non-Medical Services:
Within the Department for Technical and Related Services, the following organizational units are organized:
- Section for Fire Protection and Environmental Protection,
- Section for Maintenance of Systems and HVAC Installations,
- Section for Other Technical Services.
