The study of risks of herbal medicines production by the FMEA-analysis method
DOI:
https://doi.org/10.24959/nphj.14.2017Keywords:
risk assessment of quality, FMEA-analysis, herbal medicines, technological processAbstract
Identification and assessment of risks arising in the process of manufacture of extraction herbal medicines have been performed. The object of research was the technological process of manufacture of multicomponent tinctures and liquid extracts. Risk analysis of production is based on the results of retrospective validation of manufacture of multicomponent extraction herbal medicines, in particular “Climased” oral drops. When conducting validation the critical stages and parameters of the technological process have been determined, acceptance criteria have been specified. Identification of the possible risks for each critical stage and critical parameter of the technological process has been conducted. Expert assessments have been recorded to the form of quality risk assessment. The results of calculations of the risk priority number (RPN) have allowed to refer possible inconsistencies of the technological process at the stage of extraction to unacceptable risks. Risks arising at the stages of the raw material preparation, purification and filtration of extracts have a great impact. In the process of the risk management at the enterprise the categorization of risks (assessed level of risk) has been carried out, the methods of monitoring, prevention and risk response have been proposed; preventive measures, as well as measures in case of risk occurrence have been developed. To prevent and minimize the possible risks of pharmaceutical production the methodological approaches to functioning of the system of the risk management have been developed taking into account the manufacture of drugs based on the medicinal plant raw material.References
Александров А.В. // Фармац. отрасль. – 2011. – №5 (28). – С. 116-119.
ДСТУ ISO 9001:2009. Системи управління якістю. Вимоги (ISO 9001:2008, IDT). – Вид. офіц. – К.: Держспоживстандарт України, 2009. – 26 с.
Ефимов В.В., Барт Т.В. Статистические методы в управлении качеством продукции: Учебное пособие. – М.: КНОРУС, 2006. – 172 с.
Ляпунов М., Безугла О., Соловйов О. та ін. Настанова СТ-Н МОЗУ 42-4.2:2011 «Лікарські засоби. Управління ризиками для якості (ICH Q9)». – К.: МОЗ України, 2011. – 36 с.
Посилкіна О.В., Деренська Я.М., Костюк Г.В. Управління проектами в фармацевтичному виробництві. – Х.: НФаУ, 2010. – 544 с.
Яковенко В.К., Вишневский И.А., Георгиянц В.А. и др. // Вісник фармації. – 2013. – №1 (39). – С. 37-43.
Adama S., Suzzia D., Radekea Ch. et al. // Eur. J. of Pharmac. Sci. – 2011. – Vol. 42, Iss. 1-2. – P. 106-115.
Davie J.L. An analysis of risk perception and the RPN index within Failure Modes and Effects Analysis. – ProQuest, 2008. – 123 p.
Inoue H., Yamada Sh., // Intern. J. of Quality and Service Sci. – 2010. – Vol. 2, Iss. 3. – P. 369-382.
Yuecheng Lv., Liang Yi // J. of Chemical and Pharmac. Res. – 2014. – Vol. 6 (6). – P. 1116-1123.
Zimmermann H.F., Hentschel N. // PDA J. of Pharmac. Sci. and Technol. – 2011. – Vol. 65.5. – P. 506-512.
Downloads
Published
Issue
Section
License
Copyright (c) 2014 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).