GMP Certificate Granted to the Biotechnology Department Laboratory

The Croatian Agency for Medicinal Products (HALMED) has granted the Department of Biotechnology of the University of Rijeka a production permit and a certificate of good manufacturing practice, which is one of the most significant steps in connecting the academic community and the economy. The GMP laboratory was established through the joint efforts, investment, and vision of the Department of Biotechnology and JGL. It will carry out analyses of drug composition and contribute to the region’s economy and the Department’s self-sustainability. Around HRK 1.6m has been invested in equipment, other resources and IT infrastructure for the University lab, over HRK 1.2m of which was provided by JGL.

"We are extremely proud that, after more than a year of joint effort, we have achieved our goal – HALMED’s GMP certificate. This ensures that the Department of Biotechnology at the University of Rijeka is entered in the database of drug manufacturers. The project connects the real sector with the scientific-teaching and research sector, which helps promote the development of innovation, technology transfer and knowledge. This collaboration will strengthen JGL in terms of scientific support as part of the improvement of existing drugs and support in the development of new drugs. It will also help relieve JGL’s resources and intensify its commitment to investing in the knowledge and long-term experiences of its employees in the field of sterile pharmaceutical forms. From now on, the company will carry out part of its drug quality control and drug stability activities at the Department of Biotechnology, with the first step being cooperation on pharmaceutical forms of tablets and capsules.” said Mate Poropat, Director of Pharmaceutical and Technical Operations at JGL. He pointed out that this is the first such certificate given to an academic institution in the region and one of the few in the European Union.

"It is important to emphasise that the manufacturing licence is EU-wide. This allows the Department, in addition to doing business with JGL, to provide drug quality control services to other entities from the EU or those from third countries wishing to sell in the EU. Finally, I want to emphasise that it is a real pleasure to be part of the team that launched the first laboratory at any university in Croatia that has a GMP certificate. Such practices already exist in EU countries, but in Croatia, this is an unprecedented success. Therefore, I congratulate all involved, and trust that the cooperation will be to the satisfaction of both parties, and bring JGL additional success in future business.” concluded Poropat.

"JGL has given us exceptional trust, financial support, expertise, and the idea itself. The GMP laboratory is a platform for the highest standard of student education in an industrial and real environment within the academic community itself and provides teaching staff with industry experience. With the establishment of such a laboratory, the University of Rijeka and JGL have created a foundation for the further development of Rijeka as a centre of pharmaceutical and biotechnological development.” concluded Miranda Mladinić Pejatović, Head of the Department of Biotechnology.

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