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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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References

  1. 1.↵
    BioPhorum Operations Group. Continued Process Verification: An Industry Position Paper with Example Plan, 2014).
  2. 2.↵
    U.S. Food and Drug Administration. Guidance for Industry, Process Validation: General Principles and Practices, 2011. From http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
  3. 3.↵
    CASSS CMC Biotech Working Group. A-MAB: a Case Study in Bioprocess Development, 2009. From http://www.casss.org/?page=286.
  4. 4.↵
    European Medicines Agency. (2014). DRAFT: Guideline on Process Validation for the Manufacture of Biotechnology-Derived Active Substances and Data To Be Provided in the Regulatory Submission. From http://www.ema.europa.eu/ema/doc_index.jsp?curl=pages/includes/document/document_detail.jsp?webContentId=WC500165805&murl=menus/document_library/document_library.jsp&mid=0b01ac058009a3dc.
  5. 5.↵
    International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. Pharmaceutical Quality System Q10, 2008. From http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html.
  6. 6.↵
    1. Bissell A.F.
    “How Reliable is Your Capability Index?” Journal of the Royal Statistical Society. Series C (Applied Statistics), Vol. 39, No. 3 (1990) pp. 331–340.
    OpenUrl
  7. 7.↵
    1. Shewhart W. A.
    Economic Control of Quality of Manufactured Product; D. Van Nostrand Company, Inc.: New York, 1931.
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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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