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International Journal of Drug Regulatory Affairs (IJDRA)
Year : 2018, Volume : 6, Issue : 1
First page : ( 19) Last page : ( 25)
Print ISSN : 2321-2162. Online ISSN : 2321-6794.
Article DOI : 10.22270/ijdra.v6i1.215

Risk analysis evaluation of piroxicam 20mg capsules manufacture process by fmea technique

Priscila Cardoso*, Flávia Marotta, Kelen Siqueira

Pharmascience Indústria Farmacêutica, Minas Gerais, Brazil

*Corresponding Author's E-mail: cardosopriscila18@gmail.com

Online published on 17 September, 2019.

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 creates 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.

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Keywords

Risk analysis, FMEA, Piroxicam, manufacture process.

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