Development of guidelines on good manufacturing of biomedical cell products

The article presents the essence of draft of the Guidance of good manufacturing practices of biomedical cell products (BMCP) (GMP/GTP guideline) harmonized with the international requirements, which contains the basic quality and safety standards of clinical application of these products. These regu...

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Autores principales:	M. A. Tulina, N. V. Pyatigorskaya
Formato:	article
Lenguaje:	RU
Publicado:	Scientific Сentre for Family Health and Human Reproduction Problems 2017
Materias:	biomedical cell products legal regulation good manufacturing quality management system pharmacovigilance Science Q
Acceso en línea:	https://doaj.org/article/976656b1e49a427d9fb69723ad8f9be7
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spelling	oai:doaj.org-article:976656b1e49a427d9fb69723ad8f9be72021-11-23T06:14:37ZDevelopment of guidelines on good manufacturing of biomedical cell products2541-94202587-959610.12737/article_59f035fb9ec0d8.64599419https://doaj.org/article/976656b1e49a427d9fb69723ad8f9be72017-05-01T00:00:00Zhttps://www.actabiomedica.ru/jour/article/view/391https://doaj.org/toc/2541-9420https://doaj.org/toc/2587-9596The article presents the essence of draft of the Guidance of good manufacturing practices of biomedical cell products (BMCP) (GMP/GTP guideline) harmonized with the international requirements, which contains the basic quality and safety standards of clinical application of these products. These regulations prescribe the requirements for institutions engaged in one or more stages of BMCP production and allow to avoid any risk of contamination of cells, tissues and finished product. The aim of this work is to develop a methodology for BMCPs' quality assurance framework. Materials and methods. The main subjects of research are national and international laws and regulations, publications on quality assurance systems of cell products, problems of BMCP manufacturing and validation. Results. The draft Guidance of good manufacturing practices of BMCP (GMP/GTP guideline), including specific requirements to donor determination, biomaterial sampling and its transportation to the manufacture, to risk management system, traceability system, to processing, definition of minimally manipulated BMCP, requirements to incoming control, continuous in-process control and control of finished BMCP, to pharmacovigilance system were developed. Specific features of the manufacture of test products for non-clinical and clinical studies are described. Assessment elements for certification prior to release of each batch of test BMCP were clarified. Recommendations on the introduction of a product coding system according to ISBT 128 Standard are given in this work.M. A. TulinaN. V. PyatigorskayaScientific Сentre for Family Health and Human Reproduction Problemsarticlebiomedical cell productslegal regulationgood manufacturingquality management systempharmacovigilanceScienceQRUActa Biomedica Scientifica, Vol 2, Iss 3, Pp 58-62 (2017)
institution	DOAJ
collection	DOAJ
language	RU
topic	biomedical cell products legal regulation good manufacturing quality management system pharmacovigilance Science Q
spellingShingle	biomedical cell products legal regulation good manufacturing quality management system pharmacovigilance Science Q M. A. Tulina N. V. Pyatigorskaya Development of guidelines on good manufacturing of biomedical cell products
description	The article presents the essence of draft of the Guidance of good manufacturing practices of biomedical cell products (BMCP) (GMP/GTP guideline) harmonized with the international requirements, which contains the basic quality and safety standards of clinical application of these products. These regulations prescribe the requirements for institutions engaged in one or more stages of BMCP production and allow to avoid any risk of contamination of cells, tissues and finished product. The aim of this work is to develop a methodology for BMCPs' quality assurance framework. Materials and methods. The main subjects of research are national and international laws and regulations, publications on quality assurance systems of cell products, problems of BMCP manufacturing and validation. Results. The draft Guidance of good manufacturing practices of BMCP (GMP/GTP guideline), including specific requirements to donor determination, biomaterial sampling and its transportation to the manufacture, to risk management system, traceability system, to processing, definition of minimally manipulated BMCP, requirements to incoming control, continuous in-process control and control of finished BMCP, to pharmacovigilance system were developed. Specific features of the manufacture of test products for non-clinical and clinical studies are described. Assessment elements for certification prior to release of each batch of test BMCP were clarified. Recommendations on the introduction of a product coding system according to ISBT 128 Standard are given in this work.
format	article
author	M. A. Tulina N. V. Pyatigorskaya
author_facet	M. A. Tulina N. V. Pyatigorskaya
author_sort	M. A. Tulina
title	Development of guidelines on good manufacturing of biomedical cell products
title_short	Development of guidelines on good manufacturing of biomedical cell products
title_full	Development of guidelines on good manufacturing of biomedical cell products
title_fullStr	Development of guidelines on good manufacturing of biomedical cell products
title_full_unstemmed	Development of guidelines on good manufacturing of biomedical cell products
title_sort	development of guidelines on good manufacturing of biomedical cell products
publisher	Scientific Сentre for Family Health and Human Reproduction Problems
publishDate	2017
url	https://doaj.org/article/976656b1e49a427d9fb69723ad8f9be7
work_keys_str_mv	AT matulina developmentofguidelinesongoodmanufacturingofbiomedicalcellproducts AT nvpyatigorskaya developmentofguidelinesongoodmanufacturingofbiomedicalcellproducts
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Development of guidelines on good manufacturing of biomedical cell products

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