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Article CommentaryCommentary

A Risk-Based Auditing Process for Pharmaceutical Manufacturers

Susan Vargo, Bob Dana, Vijaya Rangavajhula and Stephan Rönninger
PDA Journal of Pharmaceutical Science and Technology March 2014, 68 (2) 104-112; DOI: https://doi.org/10.5731/pdajpst.2014.00954
Susan Vargo
1Amgen, Inc., Longmont, CO, USA;
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Bob Dana
2PDA, Bethesda, MD, USA;
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Vijaya Rangavajhula
3Divison of Acquired Immunodeficiency Syndrome, National Institutes of Health (NIH), Bethesda, MD, USA;
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Stephan Rönninger
4Amgen (Europe) GmbH, Zug, Switzerland
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References

  1. 1.↵
    International Conference on Harmonization. ICH Q9. Guideline on Quality Risk Management, November 2005.
    Google Scholar
  2. 2.↵
    1. Rönninger S.,
    2. Schmitt S.,
    3. Rangavajhula V.,
    4. Lyda J.,
    5. Hough E.
    Considerations on auditing and GxP requirements along the product life cycle. PDA J. Pharm. Sci. Technol. 2012, 66(5), 396–402.
    OpenUrlAbstract/FREE Full TextGoogle Scholar
  3. 3.↵
    PDA Technical Report No. 54 (TR 54) Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations, 2012.
    Google Scholar
  4. 4.↵
    1. Rönninger S.,
    2. Holmes M.
    A risk-based approach for scheduling audits. PDA J. Pharm. Sci. Technol. 2009, 63(6), 575–588.
    OpenUrlAbstract/FREE Full TextGoogle Scholar
  5. 5.↵
    PIC/S. A Recommended Model for Risk Based Inspection Planning in the GMP Environment. PI 037-1, January 1, 2012.
    Google Scholar
  6. 6.↵
    Health Canada. Health Products and Food Branch, Risk Classification of Post-Market Reporting Compliance Observations, Guide-0063, November 21, 2005.
    Google Scholar
  7. 7.↵
    European Medicines Agency. Compilation of Community Procedures on Inspections and Exchange of Information, EMA/INS/GMP/321252/2012/Rev. 15, July 16, 2012.
    Google Scholar
  8. 8.↵
    1. Rönninger S.,
    2. Berberich J.,
    3. Fischer G.,
    4. Persson I.,
    5. Wandt C.,
    6. Wall L.
    How can we balance value, effort and risk in foreign GMP inspections? A future perspective. GMP Review, 2012, 10, 14–18.
    OpenUrlGoogle Scholar
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PDA Journal of Pharmaceutical Science and Technology: 68 (2)
PDA Journal of Pharmaceutical Science and Technology
Vol. 68, Issue 2
March/April 2014
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A Risk-Based Auditing Process for Pharmaceutical Manufacturers
Susan Vargo, Bob Dana, Vijaya Rangavajhula, Stephan Rönninger
PDA Journal of Pharmaceutical Science and Technology Mar 2014, 68 (2) 104-112; DOI: 10.5731/pdajpst.2014.00954
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    • Abstract
    • 1. General Risk Factors to Consider for a Risk-Based Auditing Approach
    • 2. Risk-Based Approaches: From Planning to Completion
    • 3. Conclusion
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Keywords

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  • Risk assessment
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A Risk-Based Auditing Process for Pharmaceutical Manufacturers
Susan Vargo, Bob Dana, Vijaya Rangavajhula, Stephan Rönninger
PDA Journal of Pharmaceutical Science and Technology Mar 2014, 68 (2) 104-112; DOI: 10.5731/pdajpst.2014.00954

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