Research ArticleTechnology/Application
Risk-based Methodology for Validation of Pharmaceutical Batch Processes
Frederick Wiles
PDA Journal of Pharmaceutical Science and Technology July 2013, 67 (4) 387-398; DOI: https://doi.org/10.5731/pdajpst.2013.00923
Frederick Wiles
ProPharma Group, Inc., 10975 Benson Dr. Suite 330, Corporate Woods Bldg. 12, Overland Park, Kansas 66210
ASQ CQE
References
- 1.↵
FDA. Guidance for Industry. Process Validation: General Principles and Practices. Office of Communications, Division of Drug Information, Silver Spring, MD, 2011.
- 2.↵
Automotive Industry Action Group, American Society for Quality Control, Supplier Quality Requirements Task Force. Fundamental Statistical Process Control: Reference Manual. AIAG: Southfield, MI, 1991.
- 3.↵
- Both D. R.
- 4.↵
- Wald A,
- Wolfowitz J.
- 5.↵
NIST/SEMATECH e-Handbook of Statistical Methods; http://www.itl.nist.gov/div898/handbook/prc/section2/prc254.htm, retrieved September 07, 2012.
- 6.↵
- Pyzdek T.
- 7.↵
NIST/SEMATECH e-Handbook of Statistical Methods; http://www.itl.nist.gov/div898/handbook/pmc/section3/pmc32.htm, retrieved September 7, 2012.
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 67, Issue 4
July/August 2013
Risk-based Methodology for Validation of Pharmaceutical Batch Processes
Frederick Wiles
PDA Journal of Pharmaceutical Science and Technology Jul 2013, 67 (4) 387-398; DOI: 10.5731/pdajpst.2013.00923
Jump to section
Related Articles
- No related articles found.
Cited By...
- No citing articles found.