Organisation of the Work of Bioanalytical Laboratories according to the Principles of Good Clinical Laboratory Practice (Review)

Abstract

INTRODUCTION. Bioanalytical laboratories in the Russian Federation should follow the requirements of both the Good Laboratory Practices (GLP), when performing tests for non-clinical studies, and the Good Clinical Practices (GCP), when analysing samples from clinical studies. The work of such laboratories requires a separate GxP system, the Good Clinical Laboratory Practices (GCLP). However, the GCLP system has not yet been created in the Russian Federation and the Eurasian Economic Union (EAEU).АIM. This study aimed to compare the current Russian and EAEU principles regulating the work of bioanalytical laboratories with the international GCLP principles and formulate general requirements for national laboratories.DISCUSSION. The author analysed the current regulation of the work of bioanalytical laboratories, as well as the EAEU regulatory standards for the development and validation of analytical procedures. In addition, the study covered the international GCLP principles that govern the management of human resources, process record keeping, the development of standard operating procedures, the validation of analytical procedures, and the management of biological samples and reference standards in a laboratory. The author considered the key functions of a bioanalytical laboratory and suggested tools to manage them in compliance with the international GCLP principles and the EAEU requirements. It should be noted that scientific publications describe the international practice of applying the GCLP principles fairly well, and the experience of its implementation could be of use to Russian laboratories.CONCLUSION. A bioanalytical laboratory that implements the GCLP principles will increase its competitiveness in the EAEU market for bioanalytical testing services and mitigate its risks of obtaining invalid data.

Keywords

• gclp
• good clinical laboratory practices
• bioanalysis
• bioequivalence study
• efficacy and safety
• non-clinical studies
• clinical trials
• development of analytical procedures
• validation of analytical procedures
• quality management system
• bioanalytical laboratories
• glp requirements
• good laboratory practices
• gcp requirements
• good clinical practices