Metrological aspects of expert evaluation of medicinal products’ quality
Abstract
The authors of the article analysed the terms «measurement uncertainty» and «measurement error» and highlighted the main differences between them. They also analysed approaches to the assessment and expression of the measurement uncertainty that are described in the State Pharmacopoeia of the Russia, XIII edition, and guidelines of the European Directorate for the Quality of Medicines and Healthcare of the Council of Europe. The article reviews basic requirements for reporting assay results as stipulated in the guidelines of the Network of Official Medicines Control Laboratories of the European Directorate for the Quality of Medicines and Healthcare of the Council of Europe.
About the Authors
A. A. Turundaeva
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
Yu. V. Olefir
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
A. I. Lutseva
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
N. N. Gromova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
E. A. Mamashina
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
References
1. Bokovikova TN, Gernikova EP, Stronova LA, Agapkina MV, Baturina OA, Nemykina SA, et al. The main problems arising during the examination of the quality of pharmaceutical substances (quantitative assessment of the content). The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products 2016; (3): 37–41 (in Russian).
2. Kharitonov YuYa. Analytical chemistry (analytics). Book 2. Quantitative analysis. Physico-chemical (instrumental) methods of analysis. Moscow: Vysshaya shkola; 2010 (in Russian).
3. Ochir-Goryaev VP. Accuracy and uncertainty of measurements. Methodical instructions. Ukhta: UGTU; 2011 (in Russian).
4. Validation of analytical techniques. Quantitative description of uncertainty in analytical measurements. Manuals for laboratories. St. Petersburg: CEP «Profession»; 2016 (in Russian).
5. State Standard R 54500.3–2011. Guidance ISO/MEK 98-3:2008. Uncertainty of measurement. Part 3. Guidance on the expression of measurement uncertainty. Moscow: Standartinform; 2012 (in Russian).
6. Guskova LS, Evtushenko NS, Krylov YuF, Kucherenko VD. Quality control of medicines. Handbook. Moscow: Meditsina; 1986 (in Russian).
7. Romanenko VN, Orlov AG, Nikitina GV. A book for a novice chemist. Leningrad: Khimiya; 1987 (in Russian).
8. Evaluation and Reporting of Results. Core document. PA/PH/OMCL (13) 113 2R. 2014. Available from: https://goo.gl/WvmQhG.
9. Evaluation and Reporting of Results. Annex 2A. Examples of Re-test Programmes for Quantitative Tests. PA/PH/OMCL (14) 89 R. 2015. Available from: https://goo.gl/4Dn6a5.
10. State Pharmacopoeia of the Russian Federation. XIII ed. V. 1–3. Moscow; 2015. Available from: http://femb.ru/feml (in Russian).
11. Uncertainty of Measurement. Part 1. General OMCL Policy for Implementation of Measurement Uncertainty in Compliance Testing. PA/PH/OMCL (05) 49 DEF CORR. 2007. Available from: https://goo.gl/Vr1Qvr.
12. Volkova RA, Fadeikina OV. Estimation of uncertainty of test methods and reference standards used for immunobiological medicines. BIOpreparations. Prevention, Diagnosis, Treatment 2017; 17(1): 27–31 (in Russian).
13. State Standard ISO/MEK 17025–2009. General requirements for the competence of testing and calibration laboratories. Moscow: Standartinform; 2012.
Review
For citations:
Turundaeva A.A., Olefir Yu.V., Lutseva A.I., Gromova N.N., Mamashina E.A. Metrological aspects of expert evaluation of medicinal products’ quality. The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. 2017;7(4):228-232. (In Russ.)
Views:
862
Email this article 