The comparative analysis of the ISO 9001:2015 standard and Good Clinical Practice guidelines: the framework for improving management of clinical trials
Keywords:clinical trials, quality management, risk management, good clinical practice, international standard organization
The comparative analysis of the iso 9001:2015 standard and Good Clinical Practice guidelines: the framework for improving management of clinical trials
The principal concept of the ICH Q8, Q9 and Q10 guidelines is to encourage implementation of scientific and systematic approaches for quality assurance of pharmaceutical products. Clinical trials, which are the crucially important part of the pharmaceutical research and development process, are outside of these guidelines, and it actualizes the issue on introducing quality management into clinical trials.
Aim. To analyze the ISO 9001 quality management methodology and the Addendum to GCP requirements in order to elaborate the methodical background for its combined use that will provide the effective work of the quality management system while achieving GCP compliance.
Materials and methods. The methods of the comparative analysis, synthesis, generalization, abstraction and content analysis were used to determine the possibility of ISO 9001:2015 and ICH GCP integration.
Results. The Addendum to GCPdemonstrates the conformity of its provisions with prominent trends of quality management confirmed by the ISO 9001:2015 standard. The Addendum to GCP declares that the quality management system should use a risk-based approach, which allows conducting clinical trials more efficiently.
Conclusions. The ICH GCP framework can be easily and effectively integrated into the ISO 9001 quality management system of a particular clinical study, as well as in the entire system of quality assurance during the drug lifecycle. Further studies should be focused on development of the practical approaches and methods for implementation of the risk-based quality management in clinical trials.
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