FEASIBILITY STUDIES OF THE DESIGN OF PHARMACEUTICAL DEVELOPMENT AND INDUSTRIAL INTRODUCTION OF PARENTERAL PREPARATIONS ON THE BASIS OF RECOMBINANT PROTEINS
In the conditions of introduction of the proper practice of production of medicinal facilities on pharmaceutical enterprises in Ukraine, it is necessary to develop effective measures of projects management for creation of favourable conditions for modernisation of pharmaceutical production, innovative management and management of development projects. The optimization of pharmaceutical production of injection preparations, modernisation of the pharmaceutical industries, is being implemented in accordance with the standards of GMP. Risks-control of pharmaceutical production of hi-tech parenteral preparations on a new level is carried out at the following stages: preparation of raw material, preparation of facilities and equipment; the process of preparation of solution (the stage of preparation of solution, the stage of sterile filtration; filling, small bottles, ampoules and cartridges; washing small bottles, ampoules and cartridges, preparation of materials for corking, sterilization of components; soldering of ampoules, rolling of small bottles and cartridges; sterilization and checking for impermeability). Decreasing the risk focuses on the processes of reduction and prevention of risk and its causes, when the risk exceeds the indicated acceptable level. Decreasing the risk can include the measures of declining of authenticity of harm. Conclusions regarding the measures related to decreasing the risk can bring to the exposure of potential threats and new hidden risks.
Goy AM, Voskoboinikova GL, Gapon NV, et al. Feasibility studies of the design of pharmaceutical development and industrial introduction of parenteral preparations on the basis of recombinant proteins. Research Result. Medicine and Pharmacy. 2016;2(3):23-27 (In Russian). DOI: 10.18413/2313-8955-2016-2-3-23-27
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