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PDA Journal of Pharmaceutical Science and Technology

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Research ArticleResearch

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

Tim Sandle
PDA Journal of Pharmaceutical Science and Technology November 2012, 66 (6) 560-579; DOI: https://doi.org/10.5731/pdajpst.2012.00891
Tim Sandle
Bio Products Laboratory (BPL) Limited, Elstree, Hertfordshire, UK
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Article Information

vol. 66 no. 6 560-579
DOI 
https://doi.org/10.5731/pdajpst.2012.00891
PubMed 
23183652

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online November 26, 2012.

Copyright & Usage 
© PDA, Inc. 2012

Author Information

  1. Tim Sandle
  1. Bio Products Laboratory (BPL) Limited, Elstree, Hertfordshire, UK
  1. Correspondence author: Tim Sandle, c/o BPL, Dagger Lane, Elstree, Hertfordshire. Website: http://www.pharmig.blogspot.com. E-mail: tim.sandle{at}bpl.co.uk
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In This Issue

PDA Journal of Pharmaceutical Science and Technology: 66 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 66, Issue 6
November/December 2012
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Application of Quality Risk Management To Set Viable Environmental Monitoring Frequencies in Biotechnology Processing and Support Areas
Tim Sandle
PDA Journal of Pharmaceutical Science and Technology Nov 2012, 66 (6) 560-579; DOI: 10.5731/pdajpst.2012.00891

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Application of Quality Risk Management To Set Viable Environmental Monitoring Frequencies in Biotechnology Processing and Support Areas
Tim Sandle
PDA Journal of Pharmaceutical Science and Technology Nov 2012, 66 (6) 560-579; DOI: 10.5731/pdajpst.2012.00891
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Jump to section

  • Article
    • Abstract
    • Introduction
    • Quality Risk Management
    • The Risk Assessment Process
    • Environmental Monitoring
    • Application of Risk Assessment and Risk Filtering To Determine Monitoring Frequencies
    • Case Study
    • Risk Assessment Methodology
    • Hazard Identification
    • Risk Filtering
    • Monitoring
    • Risk Filtering
    • Worked Examples
    • Review of Methodology
    • Conclusion
    • References
  • Figures & Data
  • References
  • Info & Metrics
  • PDF

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  • A Model of Risk Analysis in Analytical Methodology for Biopharmaceutical Quality Control
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Keywords

  • Cleanroom
  • Environmental Monitoring
  • Good manufacturing practice
  • ISO 14644
  • quality risk management

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