Analysis of Lean Six Sigma Use in Pharmaceutical Production
DOI:
https://doi.org/10.1590/Keywords:
Lean manufacturing;, Six sigma;, Production management;, Pharmaceutical industry.Abstract
Over the last years, pharmaceutical industries have adopted continuous improvement and operational excellence programs to optimize processes, improve quality and reduce operational costs. Worldwide, Lean Manufacturing (LM) and Six Sigma (SS), as well as the integration of the two methods: Lean Six Sigma (LSS) are the most used approaches in the continuous improvement of industries and services. This work aims to investigate the employment of the Lean Six Sigma methodology in the productive areas of pharmaceutical companies located in Brazil. Interviews were conducted with managers of pharmaceutical industries that apply the approach. The results indicated the greater use of Lean Manufacturing tools compared to Six Sigma and the influence of specific peculiarities of the pharmaceutical industry on the benefits that are achieved with the use of Lean Six Sigma. The approach is considered of great value as it provides substantial benefits to the pharmaceutical industry. It is concluded that the work corroborates to the theoretical and empirical knowledge about the methodology use in the context of Brazilian pharmaceutical industries, as well as contributes to the implementation, reformulation, and improvement of Lean Six Sigma programs in this industrial segment.
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Agência Nacional de Vigilância Sanitária (Brasil). Resolução da Diretoria Colegiada nº 73, de 7 de abril de 2016. Dispõe sobre mudanças pós-registro, cancelamento de registro de medicamentos com princípios ativos sintéticos e semissintéticos e dá outras providências. Diário Oficial da União 8 abr 2016.
">Agência Nacional de Vigilância Sanitária (Brasil). Resolução da Diretoria Colegiada nº 318, de 6 de novembro de 2019. Estabelece os critérios para a realização de Estudos de Estabilidade de insumos farmacêuticos ativos e medicamentos, exceto biológicos, e dá outras providências. Diário Oficial da União 6 nov 2019.
">">Agência Nacional de Vigilância Sanitária (Brasil). Resolução da Diretoria Colegiada nº 658, de 30 de março de 2022. Dispõe sobre as diretrizes gerais de boas práticas de fabricação de medicamentos. Diário Oficial da União 31 mar 2022.
">">">Agência Nacional de Vigilância Sanitária. Guia sobre Revisão Periódica de Produtos no 9, version 2. 2018. [cited 2022 Oct 20]. Available from: Available from: http://www.sindifar.org.br/wp-content/uploads/2018/10/Guia9-2017_v2.pdf
» http://www.sindifar.org.br/wp-content/uploads/2018/10/Guia9-2017_v2.pdf
Antony J, Hoerl R, Snee R. Lean Six Sigma: yesterday, today and tomorrow. Int J Qual Reliab Manag. 2017;34(7):1073-93.
Arden NS, Fisher AC, Tyner K, Yu LX, Lee SL, Kopcha M, et al. Industry 4.0 for pharmaceutical manufacturing: Preparing for the smart factories of the future. Int. J. Pharm. 2021;602:120554.
Basu PK. Driving forces impacting pharmaceutical manufacturing and supply. In: Friedli T, Basu PK, Gronauer T, Werani J, editors. The pathway to operational excellence in the pharmaceutical industry. Aulendorf: Editio Cantor Verlag; 2010. p. 42-63.
Bellm D. Operational Excellence in the Pharmaceutical Industry - An Architecture for Emerging Markets. [Doctorate`s Dissertation]. St.Gallen: School of Management, Economics, Law, Social Sciences and International Affairs, University of St.Gallen>; 2015.
Bhatti R, Jain A, Singh H. Total Productive Maintenance (TPM) implementation practice: A literature review and directions. Int J Lean Six Sigma. 2014;5(3):293-323.
Carretero JA, Rahim A, Salah S. The integration of Six Sigma and Lean management. Int J Lean Six Sigma . 2010;1(3):249-74.
Cauchick-Miguel PA, Scheller AC, Sousa-Zomer TT. Lean Six Sigma in developing countries: evidence from a large Brazilian manufacturing firm. Int J Lean Six Sigma . 2018;12(1):3-22.
Corrêa HL, Gianesi IGN. Just in Time, MRP II e OPT: Um Enfoque Estratégico. 2a ed. São Paulo: Atlas S.A.; 1996.
Costa RDF da, Kiss C, Rodrigues PHA. A evolução recente da indústria farmacêutica brasileira nos limites da subordinação econômica. Physis Rev Saúde Coletiva. 2018. [cited 2022 Oct 20];28(1). Available from: Available from: http://www.scielo.br/scielo. php?script=sci_arttext&pid=S0103-73312018000100401&ln g=pt&tlng=pt
» http://www.scielo.br/scielo. php?script=sci_arttext&pid=S0103-73312018000100401&ln g=pt&tlng=pt
Datamarnews. Brazil is growing more dependent on imported medication. 2022. [cited 2023 Apr 20]. Available from: Available from: https://datamarnews.com/noticias/brazil-is-growing- more-dependent-on-imported-medication/
» https://datamarnews.com/noticias/brazil-is-growing- more-dependent-on-imported-medication/
Garza-Reyes, J A, Betsis, I E, Kumar, V, Radwan Al- Shboul, M. A. Lean readiness - the case of the European pharmaceutical manufacturing industry. Int J of Product Perform Manag. 2018;67(1):20-44.
Gil AC. Como elaborar projetos de pesquisa. 4a ed. São Paulo: Atlas; 2008.
Gonzalez RVD, Martins MF. Capability for continuous improvement: Analysis of companies from automotive and capital goods industries. TQM J. 2016;28(2):250-74.
Gupta S, Modgil S, Gunasekaran A. Big Data in Lean Six Sigma: a review and further research directions. Int J Prod Res. 2020;58(3):947-69.
IQVIA, Institute for Human Data Science. The Global Use of Medicines 2022-outllook to 2026. 2022. [cited 2022 Oct 15]. Available from: Available from: https://www.iqvia.com/insights/the- iqvia-institute/reports/the-global-use-of-medicines-2022
» https://www.iqvia.com/insights/the- iqvia-institute/reports/the-global-use-of-medicines-2022
IQVIA, Institute for Human Data Science. The Global Use of Medicine in 2019 and Outlook to 2023. 2019. [ cited 2022 Oct 15]. Available from: Available from: http://www.iqvia.com/institute/reports/ the-global-use-of-medicine-in-2019-and-outlook-to-2023
» http://www.iqvia.com/institute/reports/ the-global-use-of-medicine-in-2019-and-outlook-to-2023
Lotvin AM, Shrank WH, Singh SC, Falit BP, Brennan TA. Specialty medications: traditional and novel tools can address rising spending on these costly drugs. Health Aff (Millwood). 2014;33(10):1736-44.
Minayo MC de S. Amostragem e Saturação em Pesquisa Qualitativa: Consensos e Controvérsias. Rev Pesqui Qual. 2017;5(7):01-12.
Moktadir MdA, Ali SM, Mangla SK, Sharmy TA, Luthra S, Mishra N, et al. Decision modeling of risks in pharmaceutical supply chains. Ind Manag Data Syst. 2018;118(7):1388-412.
Paladini EP, Walter OMFC. Lean Six Sigma in Brazil: a literature review. Int J Lean Six Sigma . 2019;10(1):435-72.
Panwar A, Nepal BP, Jain R, Rathore APS. On the adoption of Lean manufacturing principles in process industries. Prod Plan Control. 2015;26(7):564-87.
Patel AS, Patel KM. Critical review of literature on Lean Six Sigma methodology. Int J Lean Six Sigma . 2021;12(3):627-74.
Raja Sreedharan V, Raju R. A systematic literature review of Lean Six Sigma in different industries. Int J Lean Six Sigma . 2016;7(4):430-66.
Rathi R, Singh M. A structured review of Lean Six Sigma in various industrial sectors. Int J Lean Six Sigma . 2019;10(2):622-64.
Ross JS. Pharma`s move toward small-batch processing. 2020. [cited 2022 Oct 16]. Available from: Available from: https://tabletscapsules. com/wp-content/uploads/pdf/tc_20200301_0048.pdf
» https://tabletscapsules. com/wp-content/uploads/pdf/tc_20200301_0048.pdf
Sebrae. Anuário do Trabalho na Micro e Pequena Empresa. 2013. [cited 2022 Oct 15]. Available from: Available from: https://www.sebrae.com.br/Sebrae/Portal%20Sebrae/Anexos/Anuario%20 do%20Trabalho%20Na%20Micro%20e%20Pequena%20 Empresa_2013.pdf
» https://www.sebrae.com.br/Sebrae/Portal%20Sebrae/Anexos/Anuario%20 do%20Trabalho%20Na%20Micro%20e%20Pequena%20 Empresa_2013.pdf
Shingo S. O Sistema Toyota de Produção do Ponto de Vista da Engenharia de Produção. 2a ed. Porto Alegre: Bookman; 1996.
Sieckmann F, Ngoc HN, Helm R, Kohl H. Implementation of lean production systems in small and medium-sized pharmaceutical enterprises. Procedia Manuf. 2018; 21:814-21.
Sindhwani R, Malhotra V. A framework to enhance agile manufacturing system: A total interpretive structural modelling (TISM) approach. Benchmarking Int J. 2017;24(2):467-87.
Slack N, Chambers S, Johnston R. Operations management. 5a ed. Harlow: Prentice Hall/Financial Times; 2009. 728 p.
Sousa JR de, Santos SCM dos. Análise de conteúdo em pesquisa qualitativa: modo de pensar e de fazer. Rev Pesqui E Debate Em Educ. 2020;10(2):1396-416.
Stratton SD. The Application of Lean Thinking to Pharmaceutical Quality Systems, Defining the FDA as the Customer. [Master`s Dissertation]. California: Faculty of California State, University Dominguez Hills; 2004.
Tripathi S, Rangarajan K, Talukder B. Segmental differences in pharmaceutical industry and its impact on supply chain performance. Int J Pharm Healthc Mark. 2019;13(4):516-40.
University of St. Gallen. FDA Quality Metrics Research 3rd Year Report. Switzerland: University of St. Gallen; 2019. 83 p.
Vanhoorne V, Vervaet C. Recent progress in continuous manufacturing of oral solid dosage forms. Int J Pharm. 2020; 579:1-16.
Werkema C. Criando a Cultura Lean Six Sigma. 3a ed. Rio de Janeiro: Elsevier Editora Ltda; 2012.
Yu LX, Kopcha M. The future of pharmaceutical quality and the path to get there. Int J Pharm . 2017;528(1-2):354-9.
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