Application of HACCP for development of quality risk management in a water purification system

Mayre Borges Costa; Amanda Lemette Brandão; José Carlos Pinto; Marcio Nele

doi:10.1590/s2175-97902022e191051

Authors

Mayre Borges Costa Departameno de Análises Clínicas e Toxicológicas (DACT), Faculdade de Farmácia, Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brasil https://orcid.org/0000-0002-5951-0238
Amanda Lemette Brandão Departamento de Engenharia Química e de Materiais (DEQM), Pontifícia Universidade Católica do Rio de Janeiro, Rio de Janeiro, Brasil
José Carlos Pinto Programa de Engenharia Química/COPPE, Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brasil; Departamento de Engenharia Química, Escola de Química, Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brasil
Marcio Nele Programa de Engenharia Química/COPPE, Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brasil; Departamento de Engenharia Química, Escola de Química, Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brasil

DOI:

https://doi.org/10.1590/s2175-97902022e191051%20

Keywords:

Quality, Pharmaceutical industry, Purified water, Risk, HACCP

Abstract

The present work reports the implementation of the Hazard Analysis Critical Control Point (HACCP) methodology to analyze the water purification system of a pharmaceutical site, in order to assure the system quality and prevent failures. As a matter of fact, the use of HACCP for development and implementation of Quality Risk Management (QRM) is not usual in pharmaceutical plants and it is applied here to improve the performance of the water purification system of a polymerization pilot plant used to manufacture pharmaceutical grade polymer microparticles. Critical Control Points (CCP) were determined with the aid of a decision tree and questions were made to characterize whether identified hazards constitute actual CCPs and should be monitored. When deviations were detected, corrective actions were performed and action plans were used for following-up and implementation of corrective actions. Finally, microbiological and physicochemical parameters were analyzed and the obtained results were regarded as appropriate. Therefore, it is shown that HACCP constitutes an effective tool for identification of hazards, establishment of corrective actions and monitoring of the critical control points that impact the process and the quality of the final pharmaceutical product most significantly.

Downloads

Download data is not yet available.

References

Agência Nacional de Vigilância Sanitária (Brasil). Resolução nº 17, de 16 de abril de 2010. Regulamento Técnico de Boas Práticas de Fabricação de Medicamentos. Diário Oficial da União 16 abril 2010; Seção 1.

Allata S, Valero A, Benhadia L. Implementation of traceability and food safety systems (HACCP) under the ISO 22000:2005 Standard In North Africa: The case study of an ice cream company in Algeria. Food Control. 2017;79:239-253.

Brasil. Ministério da Saúde, Agência Nacional de Vigilância Sanitária. Farmacopéia Brasileira. 6ª edição: Condutividade da água (Internet(. Brasília (DF): Ministério da Saúde, 2016a. Available at: < Available at: http://portal.anvisa.gov.br/farmacopeia-brasileira >. Accessed on: 20 Sept. 2019.

» http://portal.anvisa.gov.br/farmacopeia-brasileira

Brasil. Ministério da Saúde, Agência Nacional de Vigilância Sanitária. Farmacopéia Brasileira. 6ª edição: Água Purificada (Internet(.Brasília (DF): Ministério da Saúde , 2016b. Available at: http://portal.anvisa.gov.br/farmacopeia-brasileira >. Acessed on: 20 Sept. 2019.

» http://portal.anvisa.gov.br/farmacopeia-brasileira

Brasil. Ministério da Saúde, Agência Nacional de Vigilância Sanitária. Farmacopéia Brasileira. 6ª edição: Ensaios Microbiológicos (Internet(.Brasília (DF): Ministério da Saúde , 2016c. Available at: http://portal.anvisa.gov.br/farmacopeia-brasileira >. Acessed on: 20 Sept. 2019.

» http://portal.anvisa.gov.br/farmacopeia-brasileira

Brasil. Ministério da Saúde, Portaria nº 2.914, de 12 de dezembro de 2011 (Internet(. Brasília (DF): Available at: https://bvsms.saude.gov.br/bvs/saudelegis >. Acessed on: 02 Oct. 2019.

» https://bvsms.saude.gov.br/bvs/saudelegis

Brasil. Ministério da Saúde, Portaria de Consolidação nº 5, de 28 de setembro de 2017 (Internet(. Brasília (DF): Available at: http://bvsms.saude.gov.br/bvs/saudelegis/gm/2017/prc0005_03_10_2017.html >. Acessed on 02 Oct. 2019.

» http://bvsms.saude.gov.br/bvs/saudelegis/gm/2017/prc0005_03_10_2017.html

Bryan FL. Another Decision-Tree Approach for Identification of Critical Control Points. J Food Prot. 1996;59(11):1242-1247.

Casani S, Knochel S. Application of HACCP to water reuse in the food industry. Food Control . 13 2002;13(4-5):315-327.

Chemat F, Hoarau N. Hazard analysis and critical control point (HACCP) for an ultrasound food processing operation. Ultrason Sonochem. 2004;11(3-4):257-260.

Damikoukaa I, Katsirib A, Tzic C. Application of HACCP principles in drinking water treatment. Desalination Water Treat. 2007;210(1-3):138-145.

Daychoum M. 40+20 Ferramentas e técnicas de gerenciamento. 7a edição, Rio de Janeiro, Brasport Livros e Multimídia, Ltda, 2018.

Faisal I, Khan S, Abbasi A. Techniques and methodologies for risk analysis in chemical process industries. J Loss Prev Process Ind. 1998;11(4):261-277.

Faisal I, Rathnayaka S, Ahmed S. Methods and Models in process safety and risk management: Past, present and future. Process Saf Environ Prot. 2015;98:116-147.

Codex Alimentarius Commission, Hazard Analysis and Critical Control Point (HACCP) System and Guidelines for its Application, Annex to the Recommended International Code of Practice - General Principle of Food Hygiene, Annex to CAC / RCP 1-1969 Rev. 4, 2003. Available at: http://www.fao.org/fao-who-codexalimentarius/en/ >. Accessed at: 25 Sept. 2019.

» http://www.fao.org/fao-who-codexalimentarius/en/

Frank T, Brooks S, Creekmores R, Hasselbalch B, Murrays K, Obeng K, et al. Quality Risk Management Principles and Industry Case Studies. Pharmaceutical Quality Research Institute Manufacturing Technology Committee. 2008;1-9.

Fonseca LB, Nele M, Volpato NM, Seiceira RC, Pinto JC. Production of PPMA Nanoparticles Loaded with Praziquantel Through “In SituMiniemulsion Polymerization. Macromol React Eng. 2013;7(1):54-63.

Gil, ES. Controle fisico-químico de qualidade de medicamentos. São Paulo, Pharmabooks; 2010.

Hallen RM, Salem MY, Fatahallah FA, Abdelfattah LE. Quality in the pharmaceutical industry - A literature review. Saudi Pharm J. 2015;23(5):463-469.

Havelaar AH. Application of HACCP to drinking water supply. Food Control . 1994;5(3):145-152.

Horchner PM, Brett D, Gormley B, Jenson I, Pointon AM. HACCP Based Approach to the Derivation of on Farm Food Safety Program for the Australian red meat industry. Food Control . 2006;17(7):497-510.

Hurst WC. Integrating Hazard Analysis Critical Control Point (HACCP) and Statistical Process Control (SPC) for safer nut processing. Woodhead Publishing Limited, Georgia. USA, 2013.

Kiskó G, Szabó-Szabó O. Bioﬁlm removal of Pseudomonas strains using hot water sanitation. Acta Univ Sapientiae, Aliment. 2011;4:69-79.

Lim SAH, Antony J, Albliwi S. Statistics Process Control in the food industry - A systematic review and future research agenda. Trends Food Sci Technol. 2014;37(2):137-151.

Macêdo JAB. Biofilmes bacterianos, uma preocupação da industria farmacêutica. Rev Fármacos Med. 2000;2(7):19-24.

Moran F, Sullivan C, Keener K, Cullen P. Faciliting smart HACCP strategies with Process Analitycal Techonology. Curr Opin Food Sci. 2017;17:94-99.

Marhavilas PK, Koulouriotis DE. A risk-estimation methodological framework using quantitative assessment techniques and real accidents’ data: Application in an aluminum extrusion industry. J Loss Prev Process Ind . 2008;21(6):596-603.

Peeters JFW, Basten RJI, Tinga T. Improving failure analysis efficiency by combining FTA and FMEA in a recursive manner. Reliab Eng Syst Safe. 2018;172:36-44.

Pinto, TJA, Kaneko TM, Pinto AF. Controle Biológico de Qualidade de Produtos Farmacêuticos, Correlatos e Cosméticos, São Paulo, Editora Atheneu, 2010.

Psomas EL, Kafetzopoulos DP. HACCP effectiveness between ISO 22000 certified and non-certified dairy companies. Food Control . 2015;53:134-139.

Reddy VV, Gupta NV, Raghunandan HV, Kashyap UN. Quality risk management in Pharmaceutical industry: A review. Int J Pharnatech Res. 2014;6(3):908-914.

Reniers GLL, Pauwels N, Audenaert A, Ale BJM, Soudan K. Management of evacuation in case of fire accidents in chemicals industrial areas. J Hazard Mater. 2007;147(1-2):478-487.

Scipioni A, Saccarola G, Centazzo A, Arena F. FMEA methodology design, implementation and integration with HACCP system in a food company. Food Control . 2002;13(8):495-501.

Tixier J, Dusserre G, Salvi O, Gaston D. Review of 62 risk analysis methodologies of industrial plants. J Loss Prev Process Ind . 2002;15(4):291-303.

Trafialek J, Kolanowski W. Application of Failure Mode and Effect Analysis (FMEA) for audit of HACCP system. Food Control . 2014;44:35-44.

Wallace CA, Holyoak L, Powell SC, Dykes FC. HACCP e the difficulty with Hazard Analysis. Food Control . 2014;35(1):233-240.

World Health Organization (WHO) Expert Committee on Specifications for Pharmaceutical Preparations. Annex 2. WHO guidelines on quality risk management, In: WHO Technical Report Series No. 981; 2013.

Application of HACCP for development of quality risk management in a water purification system

Authors

DOI:

Keywords:

Abstract

Downloads

References

Downloads

Published

Issue

Section

License

How to Cite