PharmAcotechnological aspects of providing of quality of aseptic production of modern hi-tech parenterally preparations of recombinant proteins in small bottles and cartridges
DOI:
https://doi.org/10.24959/uekj.16.26Keywords:
technological process, aseptic production, hi-tech parenterally preparations, project management, pharmengineeringAbstract
In the article the pharmacotechnological aspects of providing of quality of aseptic production of modern hi-tech parenterally preparations of recombinant proteins are reflected in small bottles and cartridges. On results undertaken experimental studies the well-proven producibility of pharmacotechnological indexes of quality of production of hi-tech parenterally preparations is in small bottles and cartridges on the basis of the integrated application of principles of project management and innovations of pharmengineering of industrial pharmacy. Realizable statistical treatment of research results confirms the receipt of quality pharmaceutical product of Pharmasuline H.References
Гой А. М. Научно-методические подходы к разработке и промышленному производству новых высокотехнологичных парентеральных лекарственных средств / А. М. Гой // Modern Science – Moderní věda. – Praha. – České Republika, Nemoros. – 2015. – № 1. [Електронний ресурс]. – Режим доступу до журн.: http: // sried.at.ua
Костюк Г. В. Шляхи регламентації процесу управління проектами в умовах інтегрованої системи управління якістю / Г. В. Костюк, Я. М. Деренська // Сьогодення та майбутнє фармації: тез. доп. Всеукр. конгр. 16-19 квіт. 2008 р. – Х. : Вид-во НФаУ, 2008. – С. 534.
Перспективы производства стерильных препаратов изменились // Фармац. отрасль. – 2015. – № 1 (48). – С. 36-39.
Формування комплексної системи управління проектами у фармацевтичному виробництві в умовах впровадження належної виробничої практики: [метод. рекоменд.] / О. В. Посилкіна, Г. В. Костюк, Я. М. Деренська. – Х.: Вид-во НФаУ, 2008. – 28 с.
A Review on parenteral production technology / B. Venkateswara Reddy, B. Rasmitha Reddy, K. Navaneetha, V. Sampath Kumar// Intern. J. of Pharmacy and Biol. Sci. (IJPBS). – 2013. – Vol. 3, Issue 1. – P. 596-610.
FDA and Pharmaceutical Manufacturing Research Projects / Jeffrey T. Macher, Jackson A. Nickerson. [Электронный ресурс] – Доступ с экрана: http://apps.olin.wustl.edu/faculty/nickerson/results.
Lippincott K. Williams. Remington, the Science & Practice of Pharmacy, Parenteral Preparation, 20th ed., Vol. I. – Philadelphia: ISE publication, 2000. – 804 p.
WHO Expert Committee on Specifications for Pharmaceutical Preparations. 37 Report. Geneva, World Health Organization, 2003 (WHO Technical Report Series № 908). – Annex 7 Application of Hazard Analysis and Critical Control Point (HACCP) Methodology to Pharmaceuticals. – P. 99-112.
Downloads
Published
Issue
Section
License
Copyright (c) 2016 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).
