The comparative analysis of the ISO 9001:2015 standard and Good Clinical Practice guidelines: the framework for improving management of clinical trials

Authors

  • V. Ye. Dobrova National University of Pharmacy, Ukraine
  • K. L. Ratushna National University of Pharmacy, Ukraine
  • Ie. F. Grintsov National University of Pharmacy, Ukraine
  • N. P. Bezugla National University of Pharmacy, Ukraine

DOI:

https://doi.org/10.24959/cphj.17.1427

Keywords:

clinical trials, quality management, risk management, good clinical practice, international standard organization

Abstract

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.

Author Biographies

V. Ye. Dobrova, National University of Pharmacy

Doctor of Pharmacy (Dr. habil.), professor of the Clinical Pharmacology and Clinical Pharmacy Department

K. L. Ratushna, National University of Pharmacy

Candidate of Pharmacy (Ph.D.), teaching assistant of the Clinical Pharmacology and Clinical Pharmacy Department

Ie. F. Grintsov, National University of Pharmacy

Candidate of Medicine (Ph.D.), associate professor of the Clinical Pharmacology and Clinical Pharmacy Department

N. P. Bezugla, National University of Pharmacy

Candidate of Medicine (Ph.D.), associate professor of the Clinical Pharmacology and Clinical Pharmacy Department

References

Zupanets, K. O., Dobrova, V. Ye., Proskurnia, O. M. (2015). Upravlinnia, ekonomika ta zabezpechennia yakosti v farmatsii, 4 (42), 60–66.

Zupanets, K. O., Dobrova, V. Ye. (2016). Zaporozhskii medytcynskii zhurnal, 3 (96), 93–98.

Zupanets, К. О., Dobrova, V. Ye. (2016). Process model of the trial site quality management system. Asian Journal of Pharmaceutical and Clinical Research, 9 (3), 225–228.

Zupanets, К. О., Dobrova, V. Ye. (2016). Upravlinnia, ekonomika ta zabezpechennia yakosti v farmatsii, 6 (44), 49 – 57.

Misik, V., V. Brady, R., Bolecek, M., Klech, H. (2014). Current Trends in Globalization of Industry–Sponsored Clinical Trials. Applied Clinical Research, Clinical Trials and Regulatory Affairs, 1 (1), 56–66. doi: 10.2174/2213476x01666131111191016

Dobrova, V. Ye., Zupanets, I.A. (2012). Klinichna farmatsiia – Clinical Pharmacy, 16 (1), 18–21.

Meeker–O’Connell, A., Glessner, C., Behm, M., Mulinde, J., Roach, N., Sweeney, F., Landray, M. J. (2016). Enhancing clinical evidence by proactively building quality into clinical trials. Clinical Trials, 13 (4), 439–444. doi: 10.1177/1740774516643491

Ratushna, K. L., Zupanets, K. O., Dobrova, V. Ye., Kotenko, O. M. (2013). Upravlinnia, ekonomika ta zabezpechennia yakosti v farmatsii, 5 (31), 16 – 23.

Dobrova, V. Ye., Zupanets, K. O., Ratushna, K. L. (2013). Upravlinnia, ekonomika ta zabezpechennia yakosti v farmatsii, 1 (27), 23–28.

Zupanets., K. O., Dobrova, V. Ye., Zaichenko, A. V., Dorovskyi, O. V. (2015). Scientific and practical substantiation of ways of developing and introducing electronic case report forms to ensure the quality of bioequivalence studies. Research and Reviews: Journal of Hospital and Clinical Pharmacy, 1 (3), 21–25.

11. Quality management systems. Requirements (ISO 9001:2015). (2015).Geneva: ISO, 29.

Guideline for Good Clinical Practice. ICH Harmonised Guideline Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) (2015). International Conference оn Harmonisation оf Technical Requirements for Registration оf Pharmaceuticals for Human Use. Brussel. Available at: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R2__Addendum_Step2.pdf

Risk–Adapted Monitoring in Clinical Trials. Summary Information by ECRIN (European Clinical Research Infrastructures Network) PPI WP8/monitoring (2011). Available at: http://www.ecrin.org/fileadmin/user_upload/public_documents/News/Activities/ECRIN_proposal_ monitoring_final_28012013–1.pdf

Guideline for Industry. Oversight of Clinical Investigations. A Risk–Based Approach to Monitoring. Draft Guidance. (2011). Food and Drug Administration. N.–Y.: FDA, 41.

15. Risk–adapted approaches to the management of clinical trials of investigational medicinal products. Available at: http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingofmedicines/Clinicaltrials/index.html

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Published

2017-06-14

Issue

Section

Clinical Pharmacology and Pharmacotherapy