title: Ð¡ÑÐ°ÑÐ¸ÑÑÐ¸ÑÐµÑÐºÐ¾Ðµ ÑÐ¿ÑÐ°Ð²Ð»ÐµÐ½Ð¸Ðµ Ð¿ÑÐ¾ÑÐµÑÑÐ¾Ð¼ Ð¿ÑÐ¾Ð¸Ð·Ð²Ð¾Ð´ÑÑÐ²Ð° Ð»ÐµÐºÐ°ÑÑÑÐ²ÐµÐ½Ð½Ð¾Ð³Ð¾ Ð¿ÑÐµÐ¿Ð°ÑÐ°ÑÐ° Â«Ð­Ð¿Ð¾ÐºÑÐ¸Ð½Â»
title: Ð²ÑÐ¿ÑÑÐºÐ½Ð°Ñ ÐºÐ²Ð°Ð»Ð¸ÑÐ¸ÐºÐ°ÑÐ¸Ð¾Ð½Ð½Ð°Ñ ÑÐ°Ð±Ð¾ÑÐ° Ð¼Ð°Ð³Ð¸ÑÑÑÐ°
titleType: Subtitle
title: Statistical control of the production process of the drug Â«EpocrineÂ»
Creators: name: ÐÐ°ÑÑÐ°Ð²ÐºÐ¸Ð½Ð°, ÐÐ½Ð½Ð°
Publisher: name: Ð¡Ð°Ð½ÐºÑ-ÐÐµÑÐµÑÐ±ÑÑÐ³ÑÐºÐ¸Ð¹ Ð¿Ð¾Ð»Ð¸ÑÐµÑÐ½Ð¸ÑÐµÑÐºÐ¸Ð¹ ÑÐ½Ð¸Ð²ÐµÑÑÐ¸ÑÐµÑ ÐÐµÑÑÐ° ÐÐµÐ»Ð¸ÐºÐ¾Ð³Ð¾
Year: 2020
Subjects: Ð¢ÐµÑ Ð½Ð¾Ð»Ð¾Ð³Ð¸Ñ
Ð¿ÑÐ¾ÑÐµÑÑ Ð¿ÑÐ¾Ð¸Ð·Ð²Ð¾Ð´ÑÑÐ²Ð°
ÑÑÐ°ÑÐ¸ÑÑÐ¸ÑÐµÑÐºÐ¾Ðµ ÑÐ¿ÑÐ°Ð²Ð»ÐµÐ½Ð¸Ðµ
ÐºÐ¾Ð½ÑÑÐ¾Ð»ÑÐ½ÑÐµ ÐºÐ°ÑÑÑ Ð¨ÑÑ Ð°ÑÑÐ°
Ð²ÑÐ±Ð¾ÑÐºÐ°
Ð²Ð°ÑÐ¸Ð°ÑÐ¸Ñ
ÐºÐ°ÑÑÑ Ð¸Ð½Ð´Ð¸Ð²Ð¸Ð´ÑÐ°Ð»ÑÐ½ÑÑ Ð·Ð½Ð°ÑÐµÐ½Ð¸Ð¹ Ð¸ ÑÐºÐ¾Ð»ÑÐ·ÑÑÐ¸Ñ ÑÐ°Ð·Ð¼Ð°Ñ Ð¾Ð²
Ð¾ÑÐµÐ½ÐºÐ° Ð²Ð¾ÑÐ¿ÑÐ¾Ð¸Ð·Ð²Ð¾Ð´Ð¸Ð¼Ð¾ÑÑÐ¸ Ð¸ Ð¿ÑÐ¸Ð³Ð¾Ð´Ð½Ð¾ÑÑÐ¸
Ð»ÐµÐºÐ°ÑÑÑÐ²ÐµÐ½Ð½ÑÐµ ÑÑÐµÐ´ÑÑÐ²Ð°
production process
statistical management
Shukhart control cards
sample
variation
cards of individual values and sliding switches
assessment of reproducibility and suitability
medicinal products

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description: The given work is devoted to studying technological process of production the drug "EPOCRINÂ® solution for intravenous and subcutaneous administration of 2000 IU / ml" for statistical controllability. The work was fulfilled on the premises of FSUE Â«State. SRI OChBÂ» FMBA of Russia, where primary data for 2019 were collected from the dossier for a series of medicinal products, monitoring data at the production site, regulatory documents (standards and standard operating procedures, instructions). Calculations and construction of control charts were carried out using Microsoft Excel software, all graphical diagrams were made in KOMPAS V14. During the study, all the tasks were completed and the following conclusions were drawn: 1. At the enterprise FSUE Â«State. SRI OChBÂ» FMBA of Russia has developed, implemented and successfully operates a pharmaceutical quality system. 2. The study of the process using Shewhart's control charts showed its statistical uncontrollability within the stages of preparing water purified by temperature and checking the ampoules for tightness at the outlet. 3. The operations carried out in the erythropoietin solution preparation and sterilizing filtration, filling and sealing steps are reproducible and suitable in terms of pH, total protein and mass of solution in ampoule in two dispensers. According to the analysis, measures were proposed to increase the statistical controllability of the stages of the technological process and the costs of their implementation were estimated. Based on the calculations of the effectiveness assessment, the implementation of the recommended measures at the enterprise should be considered appropriate.