The Quality Assurance Centre. Operations
The Quality Assurance Centre is a dedicated unit under the leadership of the Head of the Quality Assurance Centre who reports directly to the Director of the Institute.
The IBA quality system has been designed to manage the quality of operations. It covers IBA organizational structures, personnel, research processes, medicinal products manufacturing and documentation. The guidelines of the quality assurance system that includes Good Laboratory Practice, Good Manufacturing Practice and Quality Management as per ISO 9001:2008 are followed in the research, delivery of analytical services and medicinal product manufacturing. The IBA operates in line with quality standards of GMP, GLP and ISO Certificates to deliver products and services that meet customer requirements and are compliant with legal regulations and respective EU Directives.
The operations of the Institute of Biotechnology and Antibiotics also include scientific, research and development works as well as the development and implementation of new technologies and research methods in the medicinal products manufacturing process. Moreover, the IBA, as an establishment responsible for and manufacturer of medicinal products, is involved in operations associated with the production, examination and analysis of the physical, chemical and microbiological properties of output materials, marketed medicinal products and medications under trial. The IBA carries out pharmacokinetics examinations, and bioavailability and bioequivalence studies.
The headship and the team of the Quality Assurance Centre carries out quality management activities in respect of documentation, training, quality audits, supplier qualifications and analytical method validation, certification of equipment and facilities, and microbiological research programs.
