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PDA Journal of Pharmaceutical Science and Technology

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Research ArticleResearch

Quality Risk Management: Putting GMP Controls First

Kevin O'Donnell, Anne Greene, Michael Zwitkovits and Nuala Calnan
PDA Journal of Pharmaceutical Science and Technology May 2012, 66 (3) 243-261; DOI: https://doi.org/10.5731/pdajpst.2012.00859
Kevin O'Donnell
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  • For correspondence: kevin.odonnell@imb.ie
Anne Greene
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Michael Zwitkovits
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Nuala Calnan
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Article Information

vol. 66 no. 3 243-261
DOI 
https://doi.org/10.5731/pdajpst.2012.00859
PubMed 
22634590

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

Copyright & Usage 
© PDA, Inc. 2012

Author Information

  1. Kevin O'Donnell1,*,
  2. Anne Greene2,
  3. Michael Zwitkovits3 and
  4. Nuala Calnan4
  1. 1Irish Medicines Board|Bord Leigheasra na hEireann, Kevin O'Malley House, Earlsfort Centre, Earlsfort Terrace, Dublin 2, Ireland;
  2. 2School of Chemical and Pharmaceutical Science, Dublin Institute of Technology, Kevin Street, Dublin 8, Ireland;
  3. 3Department für Medizinisch/Pharmazeutische Chemie, Pharmazie-Zentrum UZA II, Althanstraße 14, A-1090 Vienna, Austria; and
  4. 4School of Chemical and Pharmaceutical Science, Dublin Institute of Technology, Kevin Street, Dublin 8, Ireland
  1. ↵* Tel: +353 1 6764971. Fax: +353 1 6767836. Mobile: +353 87 9562818. kevin.odonnell{at}imb.ie
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PDA Journal of Pharmaceutical Science and Technology: 66 (3)
PDA Journal of Pharmaceutical Science and Technology
Vol. 66, Issue 3
May/June 2012
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Quality Risk Management: Putting GMP Controls First
Kevin O'Donnell, Anne Greene, Michael Zwitkovits, Nuala Calnan
PDA Journal of Pharmaceutical Science and Technology May 2012, 66 (3) 243-261; DOI: 10.5731/pdajpst.2012.00859

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Quality Risk Management: Putting GMP Controls First
Kevin O'Donnell, Anne Greene, Michael Zwitkovits, Nuala Calnan
PDA Journal of Pharmaceutical Science and Technology May 2012, 66 (3) 243-261; DOI: 10.5731/pdajpst.2012.00859
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  • Article
    • Abstract
    • Introduction
    • Exploring the Control of Risk
    • Current Problem Issues in Relation to the Use of QRM Tools in Pharmaceutical Manufacturing
    • The Classification and Evaluation of GMP Controls during QRM Exercises
    • A GMP-Tailored QRM Tool
    • Case Study: Classifying GMP Controls
    • Conclusions
    • Conflict of Interest Declaration
    • Acknowledgments
    • References
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