title: ÐÐ½Ð°Ð»Ð¸Ð· ÑÐ¸ÑÐºÐ¾Ð² Ð¿ÑÐ¸ Ð¿ÑÐ¾Ð¸Ð·Ð²Ð¾Ð´ÑÑÐ²Ðµ Ð»ÐµÐºÐ°ÑÑÑÐ²ÐµÐ½Ð½ÑÑ ÑÑÐµÐ´ÑÑÐ² Ð¸ Ð±Ð¸Ð¾Ð¿ÑÐµÐ¿Ð°ÑÐ°ÑÐ¾Ð² Ð½Ð° ÐÐ Â«Ð¤Ð°ÑÐ¼Ð°ÑÐ¸Ð½ÑÐµÐ·-ÐÐ¾ÑÐ´Â»
title: Ð²ÑÐ¿ÑÑÐºÐ½Ð°Ñ ÐºÐ²Ð°Ð»Ð¸ÑÐ¸ÐºÐ°ÑÐ¸Ð¾Ð½Ð½Ð°Ñ ÑÐ°Ð±Ð¾ÑÐ° Ð±Ð°ÐºÐ°Ð»Ð°Ð²ÑÐ°
titleType: Subtitle
title: Analysis of risks in the production of drugs and biologics at "Pharmasintez-Nord" JSC
Creators: name: ÐÐ¾Ð¹Ð²Ð¸ÑÑÐ¾Ð¹Ð½ÐµÐ½, ÐÐ½Ð°ÑÑÐ°ÑÐ¸Ñ
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: 2023
Subjects: Ð°Ð½Ð°Ð»Ð¸Ð· ÑÐ¸ÑÐºÐ¾Ð²
Ð¿ÑÐ¾Ð¸Ð·Ð²Ð¾Ð´ÑÑÐ²Ð¾
Ð¾ÑÐµÐ½ÐºÐ° ÐºÐ°ÑÐµÑÑÐ²Ð°
Ð¾ÑÐºÐ»Ð¾Ð½ÐµÐ½Ð¸Ðµ
ÐºÑÐ¾ÑÑ-ÐºÐ¾Ð½ÑÐ°Ð¼Ð¸Ð½Ð°ÑÐ¸Ñ
Ð²Ð°ÐºÑÐ¸Ð½Ð°
Ð¼Ð¾Ð½Ð¾ÐºÐ»Ð¾Ð½Ð°Ð»ÑÐ½ÑÐµ Ð°Ð½ÑÐ¸ÑÐµÐ»Ð°
risk analysis
production
quality assessment
deviation
cross-contamination
vaccine
monoclonal antibodies

description: ÐÐ°Ð½Ð½Ð°Ñ ÑÐ°Ð±Ð¾ÑÐ° Ð¿Ð¾ÑÐ²ÑÑÐµÐ½Ð° Ð¾Ð¿ÑÐµÐ´ÐµÐ»ÐµÐ½Ð¸Ñ Ð²ÐµÑÐ¾ÑÑÐ½Ð¾ÑÑÐ¸ Ð²Ð¾Ð·Ð½Ð¸ÐºÐ½Ð¾Ð²ÐµÐ½Ð¸Ñ ÑÐ¸ÑÐºÐ¾Ð² ÐºÑÐ¾ÑÑ-ÐºÐ¾Ð½ÑÐ°Ð¼Ð¸Ð½Ð°ÑÐ¸Ð¸ (Ð¿ÐµÑÐµÐºÑÐµÑÑÐ½Ð¾Ð³Ð¾ Ð·Ð°Ð³ÑÑÐ·Ð½ÐµÐ½Ð¸Ñ) Ð´Ð»Ñ Ð²ÑÐ¿ÑÑÐºÐ°ÐµÐ¼Ð¾Ð¹ Ð¿ÑÐ¾Ð´ÑÐºÑÐ¸Ð¸ ÑÐ°Ð·Ð½ÑÑ Ð³ÑÑÐ¿Ð¿ (Ð²Ð°ÐºÑÐ¸Ð½Ñ Ð¸ Ð¿ÑÐµÐ¿Ð°ÑÐ°ÑÑ Ð½Ð° Ð¾ÑÐ½Ð¾Ð²Ðµ Ð¼Ð¾Ð½Ð¾ÐºÐ»Ð¾Ð½Ð°Ð»ÑÐ½ÑÑ Ð°Ð½ÑÐ¸ÑÐµÐ») Ð¸ Ð¸Ñ Ð¿Ð¾ÑÐ»ÐµÐ´ÑÑÐ²Ð¸Ð¹, Ð¾ÑÐµÐ½ÐºÐµ, Ð° ÑÐ°ÐºÐ¶Ðµ Ð²ÑÑÐ°Ð±Ð¾ÑÐºÐµ ÑÑÑÐ°ÑÐµÐ³Ð¸Ð¸ Ð¿Ð¾ Ð¸Ñ ÑÐ¿ÑÐ°Ð²Ð»ÐµÐ½Ð¸Ñ. ÐÐ°Ð´Ð°ÑÐ¸, ÐºÐ¾ÑÐ¾ÑÑÐµ ÑÐµÑÐ°Ð»Ð¸ÑÑ Ð² ÑÐ¾Ð´Ðµ Ð¸ÑÑÐ»ÐµÐ´Ð¾Ð²Ð°Ð½Ð¸Ñ: - Ð¸Ð·ÑÑÐ¸ÑÑ ÑÐµÑÐ½Ð¾Ð»Ð¾Ð³Ð¸ÑÐµÑÐºÐ¸Ðµ Ð¿ÑÐ¾ÑÐµÑÑÑ Ð¿ÑÐ¾Ð¸Ð·Ð²Ð¾Ð´ÑÑÐ²Ð° Ð²Ð°ÐºÑÐ¸Ð½ Ð¸ Ð¿ÑÐµÐ¿Ð°ÑÐ°ÑÐ¾Ð² Ð½Ð° Ð¾ÑÐ½Ð¾Ð²Ðµ Ð¼Ð¾Ð½Ð¾ÐºÐ»Ð¾Ð½Ð°Ð»ÑÐ½ÑÑ Ð°Ð½ÑÐ¸ÑÐµÐ»; - Ð¾Ð¿ÑÐµÐ´ÐµÐ»Ð¸ÑÑ Ð²Ð¾Ð·Ð¼Ð¾Ð¶Ð½ÑÐµ Ð¸ÑÑÐ¾ÑÐ½Ð¸ÐºÐ¸, Ð¾ÑÐµÐ½Ð¸ÑÑ Ð²ÐµÑÐ¾ÑÑÐ½Ð¾ÑÑÑ ÐºÑÐ¾ÑÑ-ÐºÐ¾Ð½ÑÐ°Ð¼Ð¸Ð½Ð°ÑÐ¸Ð¸ Ð² Ð¿ÑÐ¾Ð¸Ð·Ð²Ð¾Ð´ÑÑÐ²ÐµÐ½Ð½ÑÑ ÑÑÐ»Ð¾Ð²Ð¸ÑÑ, ÑÐ´ÐµÐ»Ð°ÑÑ Ð·Ð°ÐºÐ»ÑÑÐµÐ½Ð¸Ðµ Ð¾ Ð²Ð¾Ð·Ð¼Ð¾Ð¶Ð½Ð¾ÑÑÐ¸ ÑÐ¾Ð²Ð¼ÐµÑÐµÐ½Ð¸Ñ Ð¿ÑÐ¾Ð¸Ð·Ð²Ð¾Ð´ÑÑÐ²Ð° Ð¸ Ð¿ÑÐµÐ´Ð»Ð¾Ð¶Ð¸ÑÑ Ð¼ÐµÑÑ Ð¿Ð¾ Ð¼Ð¸Ð½Ð¸Ð¼Ð¸Ð·Ð°ÑÐ¸Ð¸ ÑÐ¸ÑÐºÐ¾Ð². ÐÐ±ÑÐµÐºÑ Ð¸ÑÑÐ»ÐµÐ´Ð¾Ð²Ð°Ð½Ð¸Ñ - Ð¿ÑÐ¾Ð¸Ð·Ð²Ð¾Ð´ÑÑÐ²ÐµÐ½Ð½ÑÐ¹ ÑÑÐ°ÑÑÐ¾Ðº ÑÐ¸Ð½ÑÐµÐ·Ð° Ð¸ ÑÐ¾Ð·Ð»Ð¸Ð²Ð° Ð±Ð¸Ð¾Ð¿ÑÐµÐ¿Ð°ÑÐ°ÑÐ¾Ð², Ð³Ð´Ðµ Ð¿Ð»Ð°Ð½Ð¸ÑÑÐµÑÑÑ Ð¿ÑÐ¾Ð¸Ð·Ð²Ð¾Ð´ÑÑÐ²Ð¾ Ð»ÐµÐºÐ°ÑÑÑÐ²ÐµÐ½Ð½ÑÑ ÑÑÐµÐ´ÑÑÐ² Ð¸ Ð±Ð¸Ð¾Ð¿ÑÐµÐ¿Ð°ÑÐ°ÑÐ¾Ð². Ð Ð°Ð±Ð¾ÑÐ° Ð²ÑÐ¿Ð¾Ð»Ð½ÐµÐ½Ð° Ð½Ð° Ð±Ð°Ð·Ðµ Ð¿ÑÐµÐ´Ð¿ÑÐ¸ÑÑÐ¸Ñ ÐÐ Â«Ð¤Ð°ÑÐ¼Ð°ÑÐ¸Ð½ÑÐµÐ·-ÐÐ¾ÑÐ´Â». Ð ÑÐ¾Ð´Ðµ Ð¸ÑÑÐ»ÐµÐ´Ð¾Ð²Ð°Ð½Ð¸Ð¹ ÑÑÑÐ°Ð½Ð¾Ð²Ð»ÐµÐ½Ð¾, ÑÑÐ¾ Ð½Ð°Ð¸Ð±Ð¾Ð»ÐµÐµ ÑÑÑÐµÐºÑÐ¸Ð²Ð½ÑÐ¼ Ð¼ÐµÑÐ¾Ð´Ð¾Ð¼ Ð¾ÑÐµÐ½ÐºÐ¸ Ð²Ð¾Ð·Ð¼Ð¾Ð¶Ð½ÑÑ ÑÐ¸ÑÐºÐ¾Ð² ÐºÑÐ¾ÑÑ-ÐºÐ¾Ð½ÑÐ°Ð¼Ð¸Ð½Ð°ÑÐ¸Ð¸ Ð¿ÑÐ¸ ÑÐ¾Ð²Ð¼ÐµÑÐµÐ½Ð¸Ð¸ Ð¿ÑÐ¾Ð¸Ð·Ð²Ð¾Ð´ÑÑÐ²Ð° Ð²Ð°ÐºÑÐ¸Ð½ Ð¸ Ð¿ÑÐµÐ¿Ð°ÑÐ°ÑÐ¾Ð² Ð½Ð° Ð¾ÑÐ½Ð¾Ð²Ðµ Ð¼Ð¾Ð½Ð¾ÐºÐ»Ð¾Ð½Ð°Ð»ÑÐ½ÑÑ Ð°Ð½ÑÐ¸ÑÐµÐ» Ð² Ð¿Ð¾Ð¼ÐµÑÐµÐ½Ð¸ÑÑ Ð¸ Ð½Ð° Ð¾Ð±Ð¾ÑÑÐ´Ð¾Ð²Ð°Ð½Ð¸Ð¸ ÑÑÐ°ÑÑÐºÐ° ÑÐ¸Ð½ÑÐµÐ·Ð° Ð¸ ÑÐ¾Ð·Ð»Ð¸Ð²Ð° Ð±Ð¸Ð¾Ð¿ÑÐµÐ¿Ð°ÑÐ°ÑÐ¾Ð² ÑÐ²Ð»ÑÐµÑÑÑ Ð¼ÐµÑÐ¾Ð´ â FMEA. Ð Ð¸ÑÐº ÐºÑÐ¾ÑÑ-ÐºÐ¾Ð½ÑÐ°Ð¼Ð¸Ð½Ð°ÑÐ¸Ð¸ Ð¿ÑÐ¸ Ð¿ÑÐ¾Ð¸Ð·Ð²Ð¾Ð´ÑÑÐ²Ðµ Ð¼Ð¾Ð¶ÐµÑ Ð±ÑÑÑ Ð·Ð½Ð°ÑÐ¸ÑÐµÐ»ÑÐ½Ð¾ ÑÐ½Ð¸Ð¶ÐµÐ½ Ð·Ð° ÑÑÐµÑ Ð²ÑÐ¿Ð¾Ð»Ð½ÐµÐ½Ð¸Ñ Ð²ÑÐµÑ Ð½ÐµÐ¾Ð±ÑÐ¾Ð´Ð¸Ð¼ÑÑ Ð¼ÐµÑ Ð±ÐµÐ·Ð¾Ð¿Ð°ÑÐ½Ð¾ÑÑÐ¸ Ð¸ ÐºÐ¾Ð½ÑÑÐ¾Ð»Ñ ÐºÐ°ÑÐµÑÑÐ²Ð°. Ð¡Ð¾Ð²Ð¼ÐµÑÐµÐ½Ð¸Ðµ Ð»ÐµÐºÐ°ÑÑÑÐ²ÐµÐ½Ð½ÑÑ Ð¿ÑÐµÐ¿Ð°ÑÐ°ÑÐ¾Ð² Ð½Ð° Ð¾Ð´Ð½Ð¾Ð¼ ÑÑÐ°ÑÑÐºÐµ, Ð½Ð° Ð¾Ð´Ð½Ð¾Ð¹ Ð»Ð¸Ð½Ð¸Ð¸, Ð¿ÑÐ¸ Ð¸ÑÐ¿Ð¾Ð»ÑÐ·Ð¾Ð²Ð°Ð½Ð¸Ð¸ Ð¾Ð´Ð½Ð¾Ð³Ð¾ Ð¸ ÑÐ¾Ð³Ð¾ Ð¶Ðµ ÑÐµÑÐ½Ð¾Ð»Ð¾Ð³Ð¸ÑÐµÑÐºÐ¾Ð³Ð¾ Ð¾Ð±Ð¾ÑÑÐ´Ð¾Ð²Ð°Ð½Ð¸Ñ Ð²Ð¾Ð·Ð¼Ð¾Ð¶Ð½Ð¾ Ð¿ÑÐ¸ Ð½Ð°Ð»Ð¸ÑÐ¸Ð¸ Ð²Ð°Ð»Ð¸Ð´Ð¸ÑÐ¾Ð²Ð°Ð½Ð½ÑÑ Ð¿ÑÐ¾ÑÐµÐ´ÑÑ Ð¾ÑÐ¸ÑÑÐºÐ¸. ÐÑÐ¸ Ð½Ð°Ð¿Ð¸ÑÐ°Ð½Ð¸Ð¸ Ð»Ð¸ÑÐµÑÐ°ÑÑÑÐ½Ð¾Ð³Ð¾ Ð¾Ð±Ð·Ð¾ÑÐ° Ð¸ÑÐ¿Ð¾Ð»ÑÐ·Ð¾Ð²Ð°Ð»Ð¸ÑÑ ÑÐ»ÐµÐ´ÑÑÑÐ¸Ðµ Ð±Ð°Ð·Ñ Ð´Ð°Ð½Ð½ÑÑ: www.eaeunion.org, www.pravo.gov.ru, www.ich.org, docs.cntd.ru, pubmed.ncbi.nlm.nih.gov, www.pharmaceutical-technology.com. Ð¡ÑÐ°ÑÐ¸ÑÑÐ¸ÑÐµÑÐºÐ°Ñ Ð¾Ð±ÑÐ°Ð±Ð¾ÑÐºÐ° ÑÐºÑÐ¿ÐµÑÐ¸Ð¼ÐµÐ½ÑÐ°Ð»ÑÐ½ÑÑ Ð´Ð°Ð½Ð½ÑÑ Ð¾ÑÑÑÐµÑÑÐ²Ð»ÑÐ»Ð°ÑÑ Ñ Ð¸ÑÐ¿Ð¾Ð»ÑÐ·Ð¾Ð²Ð°Ð½Ð¸ÐµÐ¼ Ð¿Ð°ÐºÐµÑÐ° Ð¿ÑÐ¾Ð³ÑÐ°Ð¼Ð¼ Microsoft Office (Excel, Word, PowerPoint, Visio), Draw.io.
description: This work is devoted to determination of possibility of cross-contamination risks for produced products of different groups (vaccines and preparations based on monoclonal antibodies) and their consequences, estimation, and development of strategy of their management. Tasks addressed during the study: - To study technological processes of production of vaccines and preparations based on monoclonal antibodies; - Identify possible sources, assess the likelihood of cross-contamination in production conditions, conclude on the possibility of combining production and propose measures to minimize risks. The object of the study is the production site of synthesis and bottling of biopreparations, where the production of drugs and biopreparations is planned. The work was performed on the basis of "Pharmasintez-Nord" JSC enterprise. The study found that the most effective method for assessing possible risks of cross-contamination when combining the production of vaccines and drugs based on monoclonal antibodies in the premises and equipment of the synthesis and bottling site of biologics is a method - FMEA. The risk of cross-contamination during production can be significantly reduced by implementing all necessary safety and quality control measures. Cross-contamination of drugs on the same site, on the same line, using the same processing equipment is possible if there are validated cleaning procedures. The following databases were used in writing the literature review: www.eaeunion.org, www.pravo.gov.ru, www.ich.org, docs.cntd.ru, pubmed.ncbi.nlm.nih.gov, www.pharmaceutical-technology.com. Statistical processing of experimental data was carried out using the Mi-crosoft Office software package (Excel, Word, PowerPoint, Visio), Draw.io.