Abstract
In the broadest sense, a quality management system (QMS) runs by continuous interaction of elements based on processes, procedures, policies, guidelines, and resources that are compiled to guide an organization under the scope of its operational mission, vision, and objectives. QMSs in the biopharmaceutical sector defines a written and applied set of rules which aids in improvement of the quality of biopharmaceutical process engineering, while primarily assuring human tissue- and cell-based starting material and end product safety and minimizing the risk of human medicinal product recall, in the most cost-effective ways possible. This chapter aims to outline the crucial position of a QMS under the scope of good practices (GxPs) in the biopharmaceutical industry, as regards human tissue- and cell-based products.
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References
Chaudhry P, Jamieson M (2019) Good tissue practices. In: Reis RL, Gomes ME (eds) Encyclopedia of tissue engineering and regenerative medicine, vol 3. Elsevier, London
(2019) CFR–Code of Federal Regulations Title 21 Chapter I Subchapter C Part 211 current Good Manufacturing Practice for finished pharmaceuticals. U.S. Food and Drug Administration (FDA). https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=211. Accessed 25 Aug 2020
Chaloner-Larsson G, Anderson R, Egan A, da Fonseca Costa Filho MA, Gomez Herrera JF (1997) A WHO guide to Good Manufacturing Practice guidelines. World Health Organization, Geneva
(2020) Good Manufacturing Practice. European Medicines Agency (EMA). https://wwwemaeuropaeu/en/human-regulatory/research-development/compliance/good-manufacturing-practice Accessed 30 Aug 2020
(2018) EudraLex—Volume 4—Good Manufacturing Practice (GMP) Guidelines on Good Manufacturing Practice specific to advanced therapy medicinal products. European Commission (EC). https://eceuropaeu/health/sites/health/files/files/eudralex/vol-4/2017_11_22_guidelines_gmp_for_atmpspdf. Accessed 30 Aug 2020
(2017) Beşeri Tıbbi Ürün İmalathaneleri Yönetmeliği. Turkish Official Gazette. https://www.resmigazete.gov.tr/eskiler/2017/10/20171021-9.htm. Accessed 30 Aug 2020
(2019) Beşeri Tıbbi Ürünler İmalathaneleri İyi İmalat Uygulamaları (GMP) Kılavuzu. Turkish medicines and medical devices agency (TİTCK). https://titckgovtr/storage/Archive/2019/legislation/14ebd0e9-2378-491a-9c4a-27e749a82204pdf. Accessed 30 Aug 2020
Hatcher HC, Atala A, Allickson JG (2015) Landscape of cell banking: IV current good tissue practice (cGTP). In: Atala A, Allickson JG (eds) Translational and regenerative medicine. Elsevier, Amsterdam
Keitel S (2019) The guide to the quality and safety of tissues and cells for human application, 4th edn. European Directorate for the Quality of Medicines & HealthCare of the Council of Europe (EDQM), Strasbourg
(2018) CFR–Code of Federal Regulations Title 21 Chapter I Subchapter L Part 1271 human cells, tissues, and cellular- and tissue-based products Subpart D current good tissue practice. U.S. Food and Drug Administration (FDA). https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=1271.150. Accessed 30 Aug 2020
(2011) Guidance for industry current good tissue practice (CGTP) and additional requirements for manufacturers of human cells, tissues, and cellular and tissue-based products (HCT/Ps). U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research. https://www.fda.gov/media/82724/download. Accessed 30 Aug 2020
(2004) Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells. OJ. https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:102:0048:0058:en:PDF. Accessed 30 Aug 2020
(2006) Commission Directive 2006/17/EC of 8 February 2006 implementing directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells. OJ. https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2006:038:0040:0052:EN:PDF. Accessed 30 Aug 2020
(2006) Commission Directive 2006/86/EC of 24 October 2006 implementing directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells. OJ. https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32006L0086&from=EN. Accessed 30 Aug 2020
(2010) İnsan Doku ve Hücreleri ile Bunlarla İlgili Merkezlerin Kalite ve Güvenliği Hakkında Yönetmelik. Mevzuat Bilgi Sistemi. https://www.mevzuat.gov.tr/mevzuat?MevzuatNo=14389&MevzuatTur=7&MevzuatTertip=5. Accessed 30 Aug 2020
(2014) İnsan Doku ve Hücre Ürünlerinin Ruhsatlandırılması ve Bu Ürünlerin Üretim, İthalat, İhracat, Depolama ve Dağıtım Faaliyetlerini Yürüten Merkezler Hakkında Tebliğ. Mevzuat Bilgi Sistemi. https://www.mevzuat.gov.tr/mevzuat?MevzuatNo=19549&MevzuatTur=9&MevzuatTertip=5. Accessed 30 Aug 2020
Center for Compliance & Licensing National Pharmaceutical Control Bereau (2015) Good tissue practice guideline, 2nd edn. Ministry of Health, Malaysia, Kuala Lumpur
(2007) Euro-GTP guidance European Union Project in the framework of the Public Health Program. European Commission. http://goodtissuepractices.eu/images/outcomes/EuroGTP_Final_Delivery.pdf. Accessed 30 Aug 2020
Green C (2009) Current good tissue practice basics for human cells, tissues, and cellular and tissue-based products. J GxP Compliance 13(2):49–59
Fehily D, Brubaker SA, Kearny JN, Wolfinbarger L (eds) (2012) Tissue and cell processing: an essential guide. Wiley-Blackwell, Oxford
Kumbasar H, Duman B, Kurt Yüksel M et al (2020) Stem cells and psyche: perspectives and a review of the literature. J Oncol Sci 6(2):103–118. https://doi.org/10.3747/jos.2019-71899
(2015) Commission Directive (EU) 2015/565 of April 2015 amending directive 2006/86/EC as regards certain technical requirements for the coding of human tissues and cells. OJ. https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32015L0565&from=EN. Accessed 30 Aug 2020
Kilic P, Bay M, Baydin P et al (2020) Utility investigation of automated techniques in hematopoietic progenitor cell count and viability assessment in the Good Manufacturing Practice (GMP) setting. Exp Biomed Res 3(4):231–238. https://doi.org/10.30714/j-ebr.2020463606
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Kilic, P. (2021). Quality Management Systems (QMSs) of Human-Based Tissue and Cell Product Manufacturing Facilities. In: Turksen, K. (eds) Stem Cells and Good Manufacturing Practices. Methods in Molecular Biology, vol 2286. Humana, New York, NY. https://doi.org/10.1007/7651_2020_341
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DOI: https://doi.org/10.1007/7651_2020_341
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