Efforts and Development of Facilities for Testing and Research in the Area of Medical Sciences to be Compliant with OECD GLP - สภาพปัญหาและการพัฒนาขององค์กรทดสอบหรือ ศึกษาวิจัยทางวิทยาศาสตร์การแพทย์ทีได้รับการตรวจสอบ ขึนทะเบียนตามหลักการ OECD GLP

Abstract

            OECD principles of good laboratory practice, a quality system for testing or research facilities, has been implemented in Thailand since 2007. The Bureau of Laboratory Quality Standard of the Department of Medical Sciences is authorized and responsible for GLP inspection of the facilities that carried out a test or a research in the area of pharmaceutics in compliance with OECD GLP. The objective of this study was to analyze the outcomes of the inspections which would be useful for interested parties or laboratories to improve the quality system in compliance with OECD GLP. Study data were collected from 31 reports of the onsite-inspections which were performed during December 2007– January 2016 at 16 GLP test facilities. It was found that 473 non-conformities were reported against the 10 requirements of OECD GLP and the related OECD GLP documents. The most common areas where deviations and observations were reported including of clause number 9 (reporting of study results), (16.1%) and clause number 8 (performance of the study), (14.0%). The test facilities had to take corrective action to eliminate the causes of all reported non-conformities and to ensure that non-conformities would not recur in order to retain the quality system in compliance with OECD GLP. Thus, The OECD GLP program of the Depart-ment of Medical Sciences had been sucessful in increasing the number of GLP-compliance facilities which would lead to the improvement of consumer protection in Thailand.

Key words: OECD GLP, good laboratory practice, GLP inspection, non-conformities