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Research ArticlePDA Papers

Achieving “Zero” Defects for Visible Particles in Injectables

Jennifer Johns, Paolo Golfetto, Tia Bush, Gianmaurizio Fantozzi, John Shabushnig, Anthony Perry, Fran Degrazio, Dorothee Streich, Jahanvi Miller, Herve Soukiassian, Amy Stanton and Rick Watson
PDA Journal of Pharmaceutical Science and Technology November 2018, 72 (6) 640-650; DOI: https://doi.org/10.5731/pdajpst.2018.009027
Jennifer Johns
1Pfizer, Inc, N. Peapack, NJ, USA;
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Paolo Golfetto
2Stevenato Group, Via Molinella, Padua, Italy;
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Tia Bush
3Amgen Inc., West Greenwich, RI, USA;
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Gianmaurizio Fantozzi
2Stevenato Group, Via Molinella, Padua, Italy;
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John Shabushnig
4Insight Pharma Consulting, LLC, Marshall, MI, USA;
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  • For correspondence: johnshabushnig@aol.com
Anthony Perry
5Schott North America, Inc., Lebanon, PA, USA;
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Fran Degrazio
6West Pharmaceutical Services, Inc., Exton, PA, USA;
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Dorothee Streich
7Bayer AG, Kaiser-Wilhelm-Allee, Leverkusen, Germany;
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Jahanvi Miller
8Parenteral Drug Association, Bethesda, MD, USA;
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Herve Soukiassian
9Becton Dickinson, Le Pont-de-Claix, France;
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Amy Stanton
10Amgen Inc., Thousand Oaks, CA, USA;
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Rick Watson
11Merck & Co., West Point, PA, USA
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PDA Journal of Pharmaceutical Science and Technology: 72 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 72, Issue 6
November/December 2018
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Achieving “Zero” Defects for Visible Particles in Injectables
Jennifer Johns, Paolo Golfetto, Tia Bush, Gianmaurizio Fantozzi, John Shabushnig, Anthony Perry, Fran Degrazio, Dorothee Streich, Jahanvi Miller, Herve Soukiassian, Amy Stanton, Rick Watson
PDA Journal of Pharmaceutical Science and Technology Nov 2018, 72 (6) 640-650; DOI: 10.5731/pdajpst.2018.009027

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Achieving “Zero” Defects for Visible Particles in Injectables
Jennifer Johns, Paolo Golfetto, Tia Bush, Gianmaurizio Fantozzi, John Shabushnig, Anthony Perry, Fran Degrazio, Dorothee Streich, Jahanvi Miller, Herve Soukiassian, Amy Stanton, Rick Watson
PDA Journal of Pharmaceutical Science and Technology Nov 2018, 72 (6) 640-650; DOI: 10.5731/pdajpst.2018.009027
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  • Article
    • Abstract
    • 1. Introduction
    • 2. Project Structure
    • 3. Progress to Date
    • 4. Conclusions
    • Conflict of Interest Declaration
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    • APPENDIX Literature Search Document List.
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  • Demonstrating Pharmaceutical Quality System Effectiveness and Driving Continual Improvement: Evidence-Based Risk Reduction
  • PDA Points to Consider: Best Practices for Document/Data Management and Control and Preparing for Data Integrity Inspections
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Keywords

  • Injectable Products
  • Primary packaging components
  • Process Improvement
  • Risk Assessment
  • Visible Particles

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