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.;
Siegfried Schmitt
2PAREXEL;
Vijaya Rangavajhula
3HJF/DAIDS, NIH; and
Emily Hough
4PDA
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 66, Issue 5
September/October 2012
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
Jump to section
- 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
- Figures & Data
- References
- Info & Metrics
Related Articles
- No related articles found.