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Article CommentaryCommentary

A Roadmap for the Implementation of Continued Process Verification

Marcus Boyer, Joerg Gampfer, Abdel Zamamiri and Robin Payne
PDA Journal of Pharmaceutical Science and Technology May 2016, 70 (3) 282-292; DOI: https://doi.org/10.5731/pdajpst.2015.006395
Marcus Boyer
1Associate Director and Senior Scientist, Process Validation, Bristol-Myers Squibb, East Syracuse, NY, USA;
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Joerg Gampfer
2Head of Commercial Manufacturability and Platforms, Baxalta, Vienna, Austria;
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Abdel Zamamiri
3Abdelqader Zamamiri, Ph.D., Associate Director, Process Data Management, Regeneron, Rensselaer, NY, USA
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Robin Payne
3Abdelqader Zamamiri, Ph.D., Associate Director, Process Data Management, Regeneron, Rensselaer, NY, USA
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  • For correspondence: robin@biophorum.com
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Article Information

vol. 70 no. 3 282-292
DOI 
https://doi.org/10.5731/pdajpst.2015.006395
PubMed 
27020644

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online May 31, 2016.

Article Versions

  • previous version (March 28, 2016 - 17:56).
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Copyright & Usage 
© PDA, Inc. 2016

Author Information

  1. Marcus Boyer1,
  2. Joerg Gampfer2,
  3. Abdel Zamamiri3 and
  4. Robin Payne4,*
  1. 1Associate Director and Senior Scientist, Process Validation, Bristol-Myers Squibb, East Syracuse, NY, USA;
  2. 2Head of Commercial Manufacturability and Platforms, Baxalta, Vienna, Austria;
  3. 3Abdelqader Zamamiri, Ph.D., Associate Director, Process Data Management, Regeneron, Rensselaer, NY, USA
  1. ↵* Corresponding Author: Robin Payne, Ph.D., BioPhorum Operations Group (BPOG), The Studio, Kingfishers, Vyne Road, Sherborne St John, Basingstoke, Hampshire, RG24 9HX, UK; Telephone: +44 (0) 771 529 7084; e-mail: robin{at}biophorum.com
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PDA Journal of Pharmaceutical Science and Technology: 70 (3)
PDA Journal of Pharmaceutical Science and Technology
Vol. 70, Issue 3
May/June 2016
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A Roadmap for the Implementation of Continued Process Verification
Marcus Boyer, Joerg Gampfer, Abdel Zamamiri, Robin Payne
PDA Journal of Pharmaceutical Science and Technology May 2016, 70 (3) 282-292; DOI: 10.5731/pdajpst.2015.006395

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A Roadmap for the Implementation of Continued Process Verification
Marcus Boyer, Joerg Gampfer, Abdel Zamamiri, Robin Payne
PDA Journal of Pharmaceutical Science and Technology May 2016, 70 (3) 282-292; DOI: 10.5731/pdajpst.2015.006395
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  • Article
    • Abstract
    • Executive Summary
    • Introduction
    • Process Validation Stage 2
    • Process Validation Stage 3
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Keywords

  • Continued Process Verification
  • CPV
  • regulatory guidance
  • Biopharmaceutical

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