Система вторичных стандартных образцов в лабораториях контроля качества лекарственных средств
Резюме
Об авторе
Д. А. ЛеонтьевРоссия
Список литературы
1. 12. Reference standards. European Pharmacopoeia 8th edition. P. 699-702. European Directorate for the Quality of Medicines & HealthCare (EDQM). Council of Europe - 7 allee Kastner. CS 30026, F-67081 Strasbourg, France. Available from: http://online6.edqm.eu/ep802/.
2. Стандартные образцы состава и свойств веществ и материалов. Межгосударственный стандарт. ГОСТ 8.315-97. Межгосударственный Совет по Стандартизации, метрологии и сертификации. Минск; 1997.
3. Analytical Data - Interpretation and Treatment. The United States Pharmacopeia. Rockville: The United States Pharmacopeial Convention, Inc. USP 36-NF 31. Online Edition.
4. International Vocabulary of Basic and General Terms in Metrology. ISO, Geneva; 1993.
5. Леонтьев ДА. Фармацевтические стандартные образцы. В кн.: Георгиевский ВП, ред. Аналитическая химия в создании, стандартизации и контроле качества лекарственных средств. Т. 3. Харьков: НТМТ; 2012. С. 1064-1118.
6. ISO. 17025:2005. General requirements for the competence of testing and calibration laboratories. Geneva: ISO; 2005.
7. Wolf B, Ermer J. Use of Reference Standards and Quality Control: experiences and unmet needs. Pharmaceutical Reference Standards. 11th International Symposium organized by the European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe. 3-4 September 2012, Strasbourg, France. Available from: http://www.edqm.eu/en/EDQM-Downloads-527.html#966.
8. Государственная фармакопея СССР. 11-е изд. Вып. 1. М.: Медицина; 1987.
9. Арзамасцев АП, Дорофеев ВЛ, Садчикова НП. Государственные стандартные образцы лекарственных веществ (проект общей фармакопейной статьи). Ведомости Научного центра экспертизы и государственного контроля лекарственных средств 2000; (3): 24-26.
10. Reference Standards. The United State Pharmacopeia. Rockville: The United State Pharmacopeial Convention, Inc. USP 37-NF 32. P. 46-48. Online Edition.
11. GMP PIC/S. Available from: http://www.picscheme.org/publication.php.
12. EU GMP. Available from: http://ec.europa.eu/health/documents/eudralex/vol-4/index en.htm.
13. Common technical document for the registration of pharmaceuticals for human use quality overall summary of module 2 and module 3: quality (CPMP/ICH/2887/99 - Quality), July 2003. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scienti- fic_guideline/2009/09/WC500002725.pdf.
14. Jean-Louis Robert. Assessors viewpoint: expectations and findings in dossiers. Pharmaceutical Reference Standards. 11th International Symposium organized by the European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe. 3-4 September 2012, Strasbourg, France. Available from: http://www.edqm.eu/en/ EDQM-Downloads-527.html#966.
15. Clark J. Pharmaceutical Reference Standards at US FDA: Review and cGMP. Pharmaceutical Reference Standards. 11th International Symposium organized by the European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe. 3-4 September 2012, Strasbourg, France. Available from: http://www.edqm.eu/en/ EDQM-Downloads-527.html#966.
16. Hecker T. Inspector’s viewpoint: expectations and findings in GMP inspections. Pharmaceutical Reference Standards. 11th International Symposium organized by the European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe. 3-4 September 2012, Strasbourg, France. Available from: http://www.edqm.eu/en/ EDQM-Downloads-527.html#966.
17. Leontiev D. Development of the National System of Medicine Reference Substances in Ukraine. Pharmaceutical Reference Standards. 11th International Symposium organized by the European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe. 3-4 September 2012, Strasbourg, France. Available from: http://www.edqm.eu/en/EDQM-Downloads-527.html#966.
Рецензия
Для цитирования:
Леонтьев Д.А. Система вторичных стандартных образцов в лабораториях контроля качества лекарственных средств. Ведомости Научного центра экспертизы средств медицинского применения. 2016;(1):50-55.
For citation:
Leontiev D.A. The system of secondary reference standards in drug quality control laboratories. The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. 2016;(1):50-55. (In Russ.)