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;
Bob Dana
2PDA, Bethesda, MD, USA;
Vijaya Rangavajhula
3Divison of Acquired Immunodeficiency Syndrome, National Institutes of Health (NIH), Bethesda, MD, USA;
Stephan Rönninger
4Amgen (Europe) GmbH, Zug, Switzerland
References
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International Conference on Harmonization. ICH Q9. Guideline on Quality Risk Management, November 2005.
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- Rönninger S.,
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PDA Technical Report No. 54 (TR 54) Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations, 2012.
- 4.↵
- Rönninger S.,
- Holmes M.
- 5.↵
PIC/S. A Recommended Model for Risk Based Inspection Planning in the GMP Environment. PI 037-1, January 1, 2012.
- 6.↵
Health Canada. Health Products and Food Branch, Risk Classification of Post-Market Reporting Compliance Observations, Guide-0063, November 21, 2005.
- 7.↵
European Medicines Agency. Compilation of Community Procedures on Inspections and Exchange of Information, EMA/INS/GMP/321252/2012/Rev. 15, July 16, 2012.
- 8.↵
- Rönninger S.,
- Berberich J.,
- Fischer G.,
- Persson I.,
- Wandt C.,
- Wall L.
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 68, Issue 2
March/April 2014
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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