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Article CommentaryCommentary

Considerations on Auditing and GxP Requirements along the Product Lifecycle

Stephan Rönninger, Siegfried Schmitt, Vijaya Rangavajhula, Emily Hough and Jim Lyda
PDA Journal of Pharmaceutical Science and Technology September 2012, 66 (5) 396-402; DOI: https://doi.org/10.5731/pdajpst.2012.00881
Stephan Rönninger
1F. Hoffmann–La Roche Ltd.;
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  • For correspondence: Stephan.roenninger@roche.com
Siegfried Schmitt
2PAREXEL;
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Vijaya Rangavajhula
3HJF/DAIDS, NIH; and
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Emily Hough
4PDA
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Jim Lyda
4PDA
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PDA Journal of Pharmaceutical Science and Technology: 66 (5)
PDA Journal of Pharmaceutical Science and Technology
Vol. 66, Issue 5
September/October 2012
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Considerations on Auditing and GxP Requirements along the Product Lifecycle
Stephan Rönninger, Siegfried Schmitt, Vijaya Rangavajhula, Emily Hough, Jim Lyda
PDA Journal of Pharmaceutical Science and Technology Sep 2012, 66 (5) 396-402; DOI: 10.5731/pdajpst.2012.00881

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Considerations on Auditing and GxP Requirements along the Product Lifecycle
Stephan Rönninger, Siegfried Schmitt, Vijaya Rangavajhula, Emily Hough, Jim Lyda
PDA Journal of Pharmaceutical Science and Technology Sep 2012, 66 (5) 396-402; DOI: 10.5731/pdajpst.2012.00881
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  • Article
    • Abstract
    • 1. Regulatory Compliance
    • 2. Research and Development Activities
    • 3. Good Laboratory Practice (GLP) (Nonclinical/Preclinical)
    • 4. Good Clinical Practice (GCP) (Clinical; Patient & Study)
    • 5. Good Pharmacovigilance Practice (GPvP)
    • 6. Good Manufacturing Practice (GMP)
    • 7. Good Distribution Practice (GDP)
    • 8. Conclusion
    • Acknowledgments
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  • References
  • Info & Metrics
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Keywords

  • Inspection
  • Audit
  • Quality System
  • quality risk management
  • GMP
  • GDP
  • GLP
  • GCL
  • GPvP
  • GxP

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