Implementation of efficient quality management systems in organizations engaged in preclinical and clinical trials and pharmacovigilance
Abstract
The article analyses main quality assurance requirements for organizations that participate in preclinical and clinical trials and pharmacovigilance. It describes the key elements of the quality management system, provides practical advice on their implementation, and reviews the most common mistakes. The author draws attention to the necessity of implementing a holistic, risk-oriented process approach at all stages of drugs development, the importance of improving control over manufacture and circulation of investigational drugs, the need to make trial results available to general public and academic community and to apply the quality by design concept to preclinical and clinical trials in a similar way as it is now applied to drug manufacture.
Keywords
доклинические исследования,
клинические исследования,
обеспечение качества,
контроль качества,
система менеджмента качества,
фармаконадзор,
управление качеством,
preclinical trials,
clinical trials,
quality assurance,
quality control,
quality management system,
pharmacovigilance,
quality management
References
1. State Standard Ð ISO 9001–2015. Quality management systems. Requirements. Moscow: Standartinform; 2015 (in Russian).
2. Order of the Ministry of Health of the Russian Federation of 01.04.2016, No. 199 «On adoption of Good Laboratory Practice» (in Russian).
3. OECD Principles of Good Laboratory Practice (as revised in 1997).
4. Order of the Ministry of Health of the Russian Federation of 01.04.2016, No. 200n «On adoption of Good Clinical Practice» (in Russian).
5. State Standard Ð 52379–2005. Good Clinical Practice. Moscow: Standartinform; 2005 (in Russian).
6. Decree of the Board of the Eurasian Economic Commission of 29.12.2015 No. 185 «Draft resolution of the Eurasian Economic Commission Council «On adoption of Good Pharmacovigilance Practice of the Eurasian Economic Union» (in Russian).
7. The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use. Available from: http://www.ich.org/.
8. ICH Q10 Pharmaceutical Quality System. International Conference on Harmonization; 2008.
9. Integrated Addendum to ICH E6 (R1): Guideline For Good Clinical Practice E6 (R2). Step 2b version.
10. Order of the Ministry of Trade and Industry of the Russian Federation of 14.06.2013, No. 916 «On adoption of Good Manufacturing Practice» (in Russian).
11. FDA Guidance for Industry (2009): Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects.
12. State Standard R ISO 31000–2010. Risk management. Principles and guidance. Moscow: Standartinform; 2010 (in Russian).
13. ICH Q9 Quality Risk management. International Conference on Harmonization; 2006.
Review
For citations:
Manuilov D.M. Implementation of efficient quality management systems in organizations engaged in preclinical and clinical trials and pharmacovigilance. The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. 2017;7(2):126-132. (In Russ.)
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