Tool for Evaluation of Potential Risk under the Official Laboratories

Authors

  • Elizabeth Valverde Macedo Centro de Ciências Médicas, Universidade Federal Fluminense (CCM/UFF) Author
  • Isabella Fernandes Delgado Instituto Nacional de Controle de Qualidade em Saúde, Fundação Oswaldo Cruz (INCQS/FIOCRUZ) Author
  • André Luís Gemal Instituto de Química, Universidade Federal do Rio de Janeiro (IQ/UFRJ) Author

DOI:

https://doi.org/10.3395/2317-269x.00708

Keywords:

Risk, Health Surveillance, Evaluation, Drugs

Abstract

Humans are exposed to numerous technological products, among them are drugs with increasingly varied risks. Two areas of investigation permeate the environment of laboratories involved in monitoring drug quality. These are metrology and risk. The objective of this study was to elaborate a tool for evaluation of Potential Risk laboratories where tests are performed on drugs, minimizing analytical results with questionable reliability. The methodology used was based on the Model of Potential Risk Evaluation (MPRE) applied to RDC 11/12 - ANVISA / MS. The Risk Control Indicators (RCI) were planned in the Excel software. The tool contained 167 RCI. Although contains a large number of indicators, was very useful, applicable and easy to use in laboratory environment. With the help of it is possible identify the categories associated with the deviation of each RCI causes.

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Published

2015-08-26

Issue

Section

Articles

How to Cite

Tool for Evaluation of Potential Risk under the Official Laboratories. (2015). Health Surveillance under Debate: Society, Science & Technology , 3(3), 4-10. https://doi.org/10.3395/2317-269x.00708

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