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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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References

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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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