The principles of good laboratory practices in biotechnology: multicriteria decision aid (MCDA) as an innovative model for transferring knowledge
Tóm tắt
The biotechnology policy encourages the creation of networks of institutions that carry out bioassays and preclinical studies and stimulate the implementation of principles of good laboratory practice (GLP). However, it becomes essential for trained and qualified professionals to understand, develop procedures and documents, and properly implement quality management requirements to implement a laboratory quality system. The use of tools such as multicriteria decision aid (MCDA) can assist in managing and implementing the quality system in institutions and laboratories. This research aimed to demonstrate the perception of the degree of difficulty in understanding GLP principles perceived by the respondents and analyzed through the MCDA model. According to the MCDA method, a survey was carried out with 27 professionals from laboratories who answered a questionnaire with a numerical scale of very difficult, difficult, regular, neutral, and easy for each GLP requirement. Results evidenced the GLP criteria that require a smaller and greater effort to be understood and allowed the identification of efforts level to increase each GLP criteria's level of understanding. The MCDA confirms to be a robust tool to identify and validate the participants' perception of GLP criteria, considering the diversity of professionals and their different qualifications, enabling the construction of training content that considers the difficulty levels of each criterion. This strategy helps in the management of the laboratory and the dissemination of knowledge of GLP principles to biotechnology professionals, academics, and students.
Tài liệu tham khảo
Brazilian Federal Decree no 6.041 (2007) February 8th, Brasília. http://www.planalto.gov.br/ccivil_03/_Ato2007-2010/2007/Decreto/D6041.htm. Accessed June 20th, 2020 (in Portuguese).
Brazilian Federal Ordinance nº 1.078 (2018) February 27th, Brasília. http://www.lex.com.br/legis_27621380_PORTARIA_N_1078_DE_27_DE_FEVEREIRO_DE_2018.aspx. Accessed June 20th, 2020 (in Portuguese).
Souza RA, Docena C, Silva PS, Silva ABM, Brum APO (2012) Implementation of good laboratory practices (Nit-Dicla-035, Inmetro) in a technological platforms network: the Fiocruz experience. Accred Qual Assur 17:331–339
World Health Organization (2009) Handbook: good laboratory practice (GLP), Geneva
Organization for Economic Co-operation and Development (1998) OECD Principles on Good Laboratory Practice, Paris. http://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=env/mc/chem(98)17&doclanguage=en. Acessed 20 Oct 2019
Embrapa Genetic Resources and Biotechnology (2007) Implementation of GLP and NBR ISO / IEC 17.025 standards at Embrapa Genetic Resources and Biotechnology, Brasília. https://www.infoteca.cnptia.embrapa.br/infoteca/handle/doc/189432. Accessed 20 June 2020 (in Portuguese).
Digilio FA, Lanati A, Bongiovanni A, Mascia A, Di Carlo M, Barra A, Cirafici AM, Colotti G, Kisslinger A, Lacerra G, Liguori GL (2016) Quality-based model for life sciences research guidelines. Accred Qual Assur 21:221–230
Bongiovanni A, Colotti G, Liguori GL, Di Carlo M, Digilio FA, Lacerra G, Mascia A, Cirafici AM, Barra A, Lanati A, Kisslinger A (2015) Applying quality and project management methodologies in biomedical research laboratories: a public research network’s case study. Accred Qual Assur 20:203–213
Robins MM, Scarll SJ, Key PE (2006) Quality assurance in research laboratories. Accred Qual Assur 11:214–223
Tsimillis KC (2015) Training needs to understand quality assurance. Accred Qual Assur 20:53–59
Instituto Nacional de Metrologia, Qualidade e Tecnologia (2018) Nit-Dicla-035, Rio de Janeiro. http://www.inmetro.gov.br/monitoramento_BPL/documentos_aplic.asp?tOrganismo=BPL. Acessed 22 Jan 2019
Santos ER, Balottin LB, Oliveira MAL, Granjeiro JM (2015) Brazilian good laboratory practices perspective. Impact on reduction in animal use. Visa em Debate 3(2):20–28
Organization for Economic Co-operation and Development. National GLP Compliance Monitoring Programmes which participate in MAD (status and contact information). https://www.oecd.org/chemicalsafety/testing/contact-points-working-group-on-good-laboratory-practice.htm. Acessed 23 May 2022
Gusmão AOM, Silva AR, Medeiros MO (2017) Biotechnology and advances in society. Biodiversidade 16:135–154 ((in Portuguese))
Ministry of Science, Technology, Innovations and Communications (2004) Northeast Biotechnology Network, Brasília. http://www.renorbio.org/. Accessed 8 Jan 2019 (in Portuguese).
Ministry of Science, Technology, Innovations and Communications (2008) Biodiversity and Biotechnology Network of the Legal Amazon, Brasília. https://www.bionorte.org.br. Accessed 8 Jan 2019 (in Portuguese).
Ministry of Science, Technology, Innovations and Communications (2018) Biotechnology Network of the South Region, Brasília. http://www.sulbiotec.com.br. Accessed 8 Jan 2019 (in Portuguese).
Ministry of Science, Technology, Innovations and Communications (2017) National Marine Biotechnology Research Network, Brasília. http://biotecmar.com.br. Accessed 8 Janeiro 2019 (in Portuguese).
Jena GB, Chavan S (2017) Implementation of good laboratory practices (GLP) in basic scientific research: translating the concept beyond regulatory compliance. Regul Toxicol Pharmacol 89:20–25
Vijayaraghavan R, Ashok S, Swaminathan J, Kumar G (2014) GLP (good laboratory practice) guidelines in academic and clinical research: ensuring protection and safety. J Pharm Res Clin Prac 4(1):89–104
Reck AB, Schultz G (2017) Application of the multi-criteria decision support methodology in the interorganizational relationship in the poultry production chain. Rev Econ Sociol Rural 54(04):709–728 ((in Portuguese))
Lima FS, Rodrigues ECC, Silava RB, Peña CR (2016) Usability of information and communication technologies in the BRT-DF system - a constructivist analysis of user perception. R Gest Indutr 2(4):218–236 ((in Portuguese))
Giffhorn E et al (2009) Aperfeiçoamento da gestão organizacional por meio da abordagem multicritério de apoio à decisão. Revista Gestão Industrial, Paraná, v. 5, n. 4
Costa HG et al (2014) Modelo multicritério para avaliação e classificação da gestão organizacional: proposta e caso de uso. Production 24(3):521–535. https://doi.org/10.1590/s0103-65132014000300003
Bortoluzzi SC, Ensslin SR, Ensslin L (2011) Avaliação de desempenho multicritério como apoio à gestão de empresas: aplicação em uma empresa de serviços. Gestão & Produção 18(3):633–650
Baptista MAP (2000) Um modelo multicritério para avaliar o sistema de qualidade de um ambiente de produção. Universidade Federal de Santa Catarina
CAITANO, Ana Lívia et al (2019) Seleção de um modelo de treinamento para um laboratório de metrologia sob a perspectiva multicritério. In: XV Encontro Mineiro de Engenharia de Produção
Rodriguez JMM (2017) Modelo de decisão multicritério para seleção de fornecedores de equipamentos laboratoriais para pesquisa agropecuária. Dissertação de Mestrado. Universidade Federal de Pernambuco
Lourenço ATT (2016) Desempenho estratégico na gestão hospitalar: análise multicritério para suporte ao balanced scorecard. Dissertação de Mestrado. Universidade Tecnológica Federal do Paraná
Albahri, A. S. et al. Multi-Biological Laboratory Examination Framework for the Prioritization of Patients with COVID-19 Based on Integrated AHP and Group VIKOR Methods. International Journal of Information Technology & Decision Making, p. 1–23, 2020.
Quipungo PF, Rodrigues ECC, Peña CR, Braga BA (2016) Urban public transport service and its environmental impacts in the Federal District - DF – Brazil. Estudos do Cepe 44:100–112 ((in Portuguese))
Braga GS, Silva RB, Rodrigues ECC, Peña CR (2016) Analysis of service levels through the usability of intercity waterway public transport between the cities of Rio de Janeiro and Niterói. R Gest Industr 2(4):150–170 ((in Portuguese))
I Information Management Meeting (2007) The Use of Multicriteria Methodology to Support Constructivist Decision - MCDA-C for the Incorporation of the Integrative Dimension in Organizational Performance Assessment Processes, Florianópolis. http://www.anpad.org.br/admin/pdf/enadi449.pdf. Accessed 12 Jan 2018 (in Portuguese).
Carvalho VDH, Poleto T, Silva LC, Costa APCS (2015) Multicriteria approach to support strategically sustainable decisions in organizations. Revista Produção 15(3):925–947 ((in Portuguese))
Campolina AG, Soárez PC, Amaral FV, Abe JM (2017) Multicriteria decision analysis for resource allocation and health technology assessment: so far and so close? Cad Saúde Pública 33(10):e00045517 ((in Portuguese))
Goodwin M (2008) Good laboratory practice 30 years on: challenges for industry. Ann Ist Super Sanitá 44(4):369–373
Wedlich RC, Pires A, Lisa F, Fransen JM (2013) Good laboratory practice. Part 3. Implementing good laboratory practice in the analytical lab. J Chem Educ 90:862–865
Bolon B, Baze W, Shilling CJ, Keatley KL, Patrick DJ, Schafer KA (2018) Good laboratory practice in the academic setting: fundamental principles for nonclinical safety assessment and GLP-compliant pathology support when developing innovative biomedical products. ILAR J 59(1):18–28
Whitmire M, Ross R, Mwalimu J, Porter L, Whitsel M (2011) A global GLP approach to formulation analysis method validation and sample analysis. Pharm Anal Acta S 2:001. https://doi.org/10.4172/2153-2435.S2-001
Presot IM, Soares RPP, Madureira AP, Bicalho KA, Modena CM (2014) Quality perception in research laboratories from Fiocruz after QMS implementation. Rev Adm Pública 48(1):237–552
World Health Organization (2008) Training Manual: Good Laboratory Practice (GLP), Geneva.
Wedlich CR, Libera AE, Pires A, Therrien MT (2013) Good laboratory practice. Part 1. An introduction J Chem Educ 90:854–857
Wedlich RC, Libera AE, Pires A, Tellarini C (2013) Good laboratory practice. Part 2. Recording and retaining raw data. J Chem Educ 90:858–861
Organization for Economic Co-operation and Development (2017) OECD good laboratory practice: frequently asked questions (FAQ), Paris. http://www.oecd.org/chemicalsafety/testing/glp-frequently-asked-questions.htm. Accessed 4 Agu 2019
Chandrul KK, Singh D (2016) Good laboratory practice (GLP): an inclusive review. World J Pharm Res 5(4):1985–2003
Organization for Economic Co-operation and Development (2016) Position Paper Regarding the Relationship between the OECD Principles of GLP and ISO/IEC 17025, Paris. http://www.oecd.org/chemicalsafety/testing/2015_Draft20OECD.PositionPaperonRelationshipbetweenGLPISO.pdf. Acessed 20 Nov 2019
Fox, A (2003) GLP regulations vs. ISO 17025 requirements: how do they differ?. Accred Qual Assur. 8:303
Hembeck H (2002) GLP and other quality assurance systems—aA comparison. Accred Qual Assur 7:266–268
Silva AM (2018) Análise multicritério das técnicas de gestão do conhecimento no ensino a distância. 2018. Dissertação (Mestrado em Engenharia de Produção) – Faculdade de Engenharia, Universidade Estadual Paulista, Guaratinguetá
Ronchi, SH; Ensslin, SR Ensslin, L. Estruturação de um modelo Multicritério para avaliar o desempenho da tutoria de educação a distância. Revista Pretexto, Belo Horizonte, v.13, n.2, 2012.
Rodrigues AS et al (2017) Uma análise multicritério para uso de metodologias ativas no ead. IN: 23º Congresso Internacional de Educação à Distância, , Foz do Iguaçu, Anais, Foz do Iguaçu: ABED, 2017, pp 1–10.