Application of Quality Risk Management To Set Viable Environmental Monitoring Frequencies in Biotechnology Processing and Support Areas

@article{Sandle2012ApplicationOQ,
  title={Application of Quality Risk Management To Set Viable Environmental Monitoring Frequencies in Biotechnology Processing and Support Areas},
  author={Tim Sandle},
  journal={PDA Journal of Pharmaceutical Science and Technology},
  year={2012},
  volume={66},
  pages={560 - 579}
}
  • Tim Sandle
  • Published 1 November 2012
  • Environmental Science
  • PDA Journal of Pharmaceutical Science and Technology
Environmental monitoring programs are essential for pharmaceutical facilities in order to assess the level of environmental control. For biotechnology facilities there is little advice as to the frequency at which viable environmental monitoring should be conducted. This paper outlines an approach, based on the principles of quality risk management, for the development of a framework from which monitoring frequencies can be determined. This involved the identification of common hazards and the… 

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