Development of the model for the non-conformance correction and prevention process in clinical trials
Keywords:clinical trial quality management, corrective action, preventive action, risk management
The use of the CAPA-planning method to correct and prevent the risks emergence when organizing and conducting clinical trials (CT) of new drugs can close the cycle of actions between identifying the problem and the action to solve it. Our preliminary analysis of regulatory documentation showed the lack of unified harmonized requirements for this type of processes when organizing and conducting CT.
Aim. To develop the algorithm for using the CAPA-planning method during the process of non-conformance correction and prevention when organizing and conducting CT.
Materials and methods. The practical approaches used to develop CAPA-plans were assessed. The algorithm for the process of non-conformance correction and prevention was created. Methods of meta-analysis, abstraction, synthesis and generalization were used in this work.
Results. Our analysis of the experience of using organizational structures for designing CAPA-plans has shown that the most convenient and effective for work is the form of drafting and execution of the CAPA-plan in the form of a consolidated table of all non-conformances identified. Quality management of CT using the CAPA-planning method is a multi-stage process that begins with non-conformance identification during the inspection or control and ends with the documented correction and prevention of all non-conformances identified.
Conclusions. A review of the existing methods for organizing CAPA-plans indicates the absence of the general principles for their drafting, registration and work with them. The algorithm for the interfunctional process for non-conformance correction and prevention with the help of the CAPA-planning method has been developed.
Meeker-O’Connell, A., Sam, L. M., Bergamo, N., & Little, J. A. (2016). TransCelerate’s Clinical Quality Management System. Therapeutic Innovation & Regulatory Science, 50(4), 397–413. https://doi.org/10.1177/2168479016651300
Kolodyezna, T., Zupanets, K., Dobrova, V. (2018). Evaluation of opportunities for the use of modern methods for correction and prevention of risks in the quality control of clinical trials. ScienceRise: Pharmaceutical Science, 5 (15), 10–16.
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: Journal of the Society for Clinical Trials, 13(4), 439–444. https://doi.org/10.1177/1740774516643491
Zupanets, E. A., & Dobrova, V. Y. (2016). The analysis of specialists’ opinion on the implementation of concept of risk management in clinical trials of drugs. Zaporozhye Medical Journal, 3, 93–98. https://doi.org/10.14739/2310-1210.2016.3.77004
Meeker-O’Connell, A., Borda, M. M., Little, J. A., & Sam, L. M. (2015). Enhancing Quality and Efficiency in Clinical Development Through a Clinical QMS Conceptual Framework. Therapeutic Innovation & Regulatory Science, 49(5), 615–622. https://doi.org/10.1177/2168479015596018
Callery-D’Amico, S., Sam, L. M., Grey, T. H., & Greenwood, D. J. (2016). TransCelerate’s Clinical Quality Management System. Therapeutic Innovation & Regulatory Science, 50(5), 530–535. https://doi.org/10.1177/2168479016657129
Guideline ICH GCP E6 (R2) Step 5 Addendum. (2016). Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002874.pdf
ICH Q10 Nastanova «Likarski zasobi. Farmatsevtichna sistema yakosti». (2011). Available at: http://www.gmpua.com/World/Ukraine/nastanova42432011.pdf
ICH GCP Nastanova «Likarski zasobi. Nalezhna klinichna praktika». (2009). Available at: http://www.gmpua.com/World/Ukraine/nastanova42702008.pdf
Standard ISO 9001:2015. (2015). Available at: http://pqm-online.com/assets/files/pubs/translations/std/iso-9001-2015-(rus).pdf
Official web-site of research center at Loughborough University. (n.d.). Available at: https://www.lboro.ac.uk/research/
Mehra, M., Kurpanek, K., Petrizzo, M., Brenner, S., McCracken, Y., Katz, T., & Gurian, M. (2014). The Life Cycle and Management of Protocol Deviations. Therapeutic Innovation & Regulatory Science, 48(6), 762–777. https://doi.org/10.1177/2168479014530119
Official web-site of research center at Cleveland Medical Center University Hospitals. (n.d.). Available at: http://www.uhhospitals.org/clinical-research/clinical-research-center-core-offices/research-compliance-education-and-outreach
Official web-site of research center at USF Health CRC. (n.d.). Available at: https://health.usf.edu/medicine/research/ocr/morsani-clinical-research
Official web-site of research center at UW Institute for Clinical and Translational Research. (n.d.). Available at: https://ictr.wisc.edu/
Copyright (c) 2018 National University of Pharmacy
This work is licensed under a Creative Commons Attribution 4.0 International License.Authors who publish with this journal agree to the following terms:
- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution License that allows others to share the work with an acknowledgement of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgement of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).