KTU Drug and Pharmaceutical Technology Application and Research Center (ILAFAR) operates in the development of pharmaceutical active substance formulations in the fields of human, agricultural, and veterinary medicine. It conducts preclinical research and development (R&D) studies, engaging in high-tech research in these areas, with a vision for national and international recognition. Endeavoring for these achievements, ILAFAR has been awarded the "OECD Good Laboratory Practices (GLP) Compliance Certificate" following audits by the Turkish Accreditation Agency (TÜRKAK).

Good Laboratory Practices (GLP) constitute a quality system related to the planning, performing, monitoring, recording, retaining, and reporting of non-clinical health and environmental safety studies. The principles of GLP aim to ensure the quality, reliability, and integrity of the study, the documentation of verifiable results, and the archiving of records.

OECD Principles of Good Laboratory Practice (GLP) were established as managerial control systems by governments to ensure the quality and data reliability of future scientific safety studies. The internationally harmonized GLP Principles were organized by the Organisation for Economic Co-Operation and Development (OECD) and published in 1981. In many countries, compliance with the OECD GLP is incorporated into laws as a managerial control mechanism.

The focal point of the Principles of OECD GLP is the originality of studies. These principles constitute quality control systems that lay down the conditions for laboratories. As compliance with Good Laboratory Practices (GLP) is ensured in OECD (Organisation for Economic Co-Operation and Development) countries, governments have confidence in accepting data from other countries, considering that it is valid and of acceptable quality.

The Turkish Accreditation Agency (TÜRKAK), which ensures the quality and assurance of products and services launched in the national and international markets, is the sole authorized national authority in accreditation in Türkiye. TÜRKAK is the world's 10th largest and Europe's 5th largest accreditation body.

Operating under the Ministry of Foreign Affairs of the Republic of Türkiye, TÜRKAK completed the audit process for ILAFAR, which applied in 2022, through a preliminary audit on August 16, 2022, a full audit between May 15-17, 2023, and a follow-up audit on November 11, 2023. As a result of the audits, on January 23, 2024, the TÜRKAK Administrative Board issued a Certificate of Compliance with OECD Good Laboratory Practice to ILAFAR.

In Türkiye, there are 12 centers with the OECD GLP Compliance Certificate, including ILAFAR. Out of these centers, 9 operate in the private sector, 1 is under the Ministry of Health of the Republic of Türkiye, and 2 operate within state universities. With the success of ILAFAR, our university has become one of the two state universities with this accreditation.

With the obtained OECD Good Laboratory Practice Compliance Certificate, ILAFAR is expected to contribute to our university's "Research University" brand value and international recognition. Additionally, it is anticipated to support the increase in the national and local ratio in the pharmaceutical and medical device sector, which is one of the priority sectors in Türkiye's 12th Development Plan, through its successful testing, analysis, and research activities.

During his visits to observe successful scientific work conducted at ILAFAR, our Rector, Prof. Dr. Hamdullah Çuvalcı, commended the efforts of the Director of the Drug and Pharmaceutical Technology Application and Research Center, Prof. Dr. F. Sena Sezen, as well as all the academic and administrative staff of ILAFAR. He congratulated them for their dedication in the process of producing successful scientific research, the original studies they contributed to the literature, and the tangible outcome of these efforts, like the Certificate. The Rector expressed his best wishes for the continuation of successful research within ILAFAR.

 

Önceki Sonraki