Research ArticleResearch
How Many Batches Are Needed for Process Validation under the New FDA Guidance?
Harry Yang
PDA Journal of Pharmaceutical Science and Technology January 2013, 67 (1) 53-62; DOI: https://doi.org/10.5731/pdajpst.2013.00902
Harry Yang
MedImmune LLC, One MedImmune Way, Gaithersburg, MD 20878
References
- 1.↵
U.S. FDA Guidance for Industry on Process Validation: General Principles and Practices, 2011.
- 2.↵
ICH Q8(R2). Pharmaceutical Development, 2006.
- 3.↵
ICH Q9. Quality Risk Management, 2007.
- 4.↵
ICH Q10. Pharmaceutical Quality Systems, 2007.
- 5.↵
ICH Q11. Concept Paper, 2011.
- 6.↵
FDA Guideline on General Principles of Process Validation. FDA: Rockville, MD, May, 1987.
- 7.↵
- Berger J. O
- 8.↵
- 9.↵
- Spiegelhalter D. J.,
- Abrams K. R.,
- Myles J. P
- 10.↵
- Hahn G. J.,
- Nelson W. A
- 11.↵
- Agresti A
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 67, Issue 1
January/February 2013
How Many Batches Are Needed for Process Validation under the New FDA Guidance?
Harry Yang
PDA Journal of Pharmaceutical Science and Technology Jan 2013, 67 (1) 53-62; DOI: 10.5731/pdajpst.2013.00902
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