Risk-based Methodology for Validation of Pharmaceutical Batch Processes

Frederick Wiles

doi:10.5731/pdajpst.2013.00923

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

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For correspondence: fred.wiles@propharmagroup.com

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vol. 67 no. 4 387-398

DOI

https://doi.org/10.5731/pdajpst.2013.00923

PubMed

23872447

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Published online July 19, 2013.

Author Information

Frederick Wiles, ASQ CQE*

ProPharma Group, Inc., 10975 Benson Dr. Suite 330, Corporate Woods Bldg. 12, Overland Park, Kansas 66210

↵* Corresponding Author: ProPharma Group, Inc., 10975 Benson Dr. Suite 330, Corporate Woods Bldg. 12, Overland Park, Kansas 66210, E-mail: fred.wiles{at}propharmagroup.com

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PDA Journal of Pharmaceutical Science and Technology

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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

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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

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Keywords

Process capability
Statistical confidence
Statistical coverage
Control Chart
PFMECA
Process validation
Risk-based.

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