RISK ANALYSIS EVALUATION OF PIROXICAM 20MG CAPSULES MANUFACTURE PROCESS BY FMEA TECHNIQUE

  • Priscila Cardoso Pharmascience Pharmaceutical Industry
  • Marotta Flávia
  • Siqueira Kelen

Abstract

This paper presents an application of FMEA (Failure Mode and Effects Analysis) on the manufacturing process of piroxicam 20mg capsules, with the objective of identifying possible failures and create subsidies for improvement of the production stages. Brainstorming or Collaborative critical analysis was used as a tool to collect information and support FMEA’s application. After the risk analysis, evaluation of the production process using FMEA, manipulation and secondary packaging were found to be the critical stages in the production process necessary for implementation of actions in order to mitigate the risks.

Keywords: risk analysis, FMEA, piroxicam, manufacture process

Downloads

Download data is not yet available.

References

1. ICH. Quality Risk Management Q9. [Internet]. International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use, 2005 November 09. [Cited 2018 February 01]. Available from:
https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q9/Step4/Q9_Guideline.pdf
2. Lewis GA, Mathieu D, Phan-Tan-Luu R. Pharmaceutical Experimental Design. New York: Marcel Dekker; 1999.
3. Moretto LD, Calixto J. Estrutura do Novo Sistema da Qualidade para a Indústria Farmacêutica. São Paulo: Sindusfarma; 2011.
4. Brasil. Law nº 8080/1990. [Internet]. Official Diary of the Union, 1990, September 19. [Cited 2018 February 01]. Available from:
http://www2.camara.leg.br/legin/fed/lei/1990/lei-8080-19-setembro-1990-365093-normaatualizada-pl.pdf
5. Brasil. Resolution of the collegiate board of ANVISA nº 17/2010. [Internet]. Official Diary of the Union, 2010 April 16. [Cited 2018 January 01]. Available from:
http://bvsms.saude.gov.br/bvs/saudelegis/anvisa/2010/res0017_16_04_2010.html
6. Brasil. Resolution of the collegiate board of ANVISA nº 60/2014. [Internet]. Official Diary of the Union, 2014 October 10. [Cited 2018 January 01]. Available from:
http://bvsms.saude.gov.br/bvs/saudelegis/anvisa/2014/rdc0060_10_10_2014.pdf
7. Brasil. Resolution of the collegiate board of ANVISA nº 200/2010. [Internet]. Official Diary of the Union, 2017 December 26. [Cited 2018 January 01]. Available from:
http://www.poderesaude.com.br/novosite/images/Publica%C3%A7%C3%A3o_3_-_28.12.2017.pdf
8. Brasil. Resolution of the collegiate board of ANVISA nº 73/2016. [Internet]. Official Diary of the Union. 2016 April 7. [Cited 2018 January 20] Available from: http://bvsms.saude.gov.br/bvs/saudelegis/anvisa/2016/rdc0073_07_04_2016.pdf
9. Kayrak-Talay D, Dale S, Wassgren C, Litster J. Quality by design for wet granulation in pharmaceutical processing: Assessing models for a priori design and scaling. Powder Technology. 2013; 240:7-18.
10. Sidor L, Lewus P. Validation & Compliance: Using Risk Analysis in Process Validation. BioPharm International. 2007; 20(2):1-7
11. Mcdermott R, Mikulak R, Beauregard M. The basics of FMEA. 2nd ed. New York: Productivity Press; 2009.
12. Mascia S, Heider PL, Zhang H, Lakerveld R, Benyahia B, Barton PI. End-to-end continuous manufacturing of pharmaceuticals: integrated synthesis, purification, and final dosage formation. Angewandte Chemie International Edition. 2013; 52:12359–12363.
13. Leeuwen JFV, Nauta MJ, Kaste D, Odekerken-Rombouts YMCF, Oldenhof MT, Vredenbregt MJ, Barends DM. Risk analysis by FMEA as an element of analytical validation. Journal of pharmaceutical and biomedical analysis. 2009; 50(5):1085-87.
14. Brunton LL, Lazo JS, Parker KL. As Bases Farmacológicas da Terapêutica de Goodman & Gilman.12nd ed. Rio de Janeiro: McGraw Hill; 2006.
15. Brasil. Farmacopeia Brasileira. 5th ed. Brasília: Agência Nacional de Vigilância Sanitária; 2010. p. 59-65.
16. Brasil. Farmacopeia Brasileira. 5th ed. Brasília: Agência Nacional de Vigilância Sanitária; 2010. p. 1204-1205
17. Yu LX, Amidon G, Khan MA, Hoag SW, Polli J, Raju GK. Understanding pharmaceutical quality by design. AAPS Journal. 2014; 16:771-83.
18. Helman H, Andery PRP. Análise de Falhas. Aplicação de FMEA e FTA. 1st ed. Belo Horizonte: Fundação Cristiano Ottoni; 1995.
19. Lachman L, Lieberman HA, Kanig JL. The theory and practice of industrial pharmacy. 3rd ed. Mumbai: Varghese Publishing House; 1987. p. 3-18.
Statistics
98 Views | 131 Downloads
How to Cite
Cardoso, P., M. Flávia, and S. Kelen. “RISK ANALYSIS EVALUATION OF PIROXICAM 20MG CAPSULES MANUFACTURE PROCESS BY FMEA TECHNIQUE”. International Journal of Drug Regulatory Affairs, Vol. 6, no. 1, Mar. 2018, pp. 19-25, doi:https://doi.org/10.22270/ijdra.v6i1.215.