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Review ArticlePQRI Special Section

The Product Quality Research Institute (PQRI) Leachables and Extractables Working Group Initiatives for Parenteral and Ophthalmic Drug Product (PODP)

Diane Paskiet, Dennis Jenke, Douglas Ball, Christopher Houston, Daniel L. Norwood and Ingrid Markovic
PDA Journal of Pharmaceutical Science and Technology September 2013, 67 (5) 430-447; DOI: https://doi.org/10.5731/pdajpst.2013.00936
Diane Paskiet
1West Pharmaceutical Services, Exton PA, USA;
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  • For correspondence: diane.paskiet@westpharma.com
Dennis Jenke
2Baxter Healthcare Corporation, Round Lake, IL, USA;
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Douglas Ball
3Pfizer, Inc., Groton, CT, USA;
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Christopher Houston
4Bausch & Lomb, Rochester, NY, USA;
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Daniel L. Norwood
5Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA; and
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Ingrid Markovic
6United States Food and Drug Administration, Washington, DC, USA
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PDA Journal of Pharmaceutical Science and Technology: 67 (5)
PDA Journal of Pharmaceutical Science and Technology
Vol. 67, Issue 5
September/October 2013
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The Product Quality Research Institute (PQRI) Leachables and Extractables Working Group Initiatives for Parenteral and Ophthalmic Drug Product (PODP)
Diane Paskiet, Dennis Jenke, Douglas Ball, Christopher Houston, Daniel L. Norwood, Ingrid Markovic
PDA Journal of Pharmaceutical Science and Technology Sep 2013, 67 (5) 430-447; DOI: 10.5731/pdajpst.2013.00936

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The Product Quality Research Institute (PQRI) Leachables and Extractables Working Group Initiatives for Parenteral and Ophthalmic Drug Product (PODP)
Diane Paskiet, Dennis Jenke, Douglas Ball, Christopher Houston, Daniel L. Norwood, Ingrid Markovic
PDA Journal of Pharmaceutical Science and Technology Sep 2013, 67 (5) 430-447; DOI: 10.5731/pdajpst.2013.00936
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  • Article
    • Abstract
    • Introduction
    • Chemical Aspects of Safety Assessment—The Chemistry Team
    • Toxicological Aspects of Safety Assessment—The Toxicology Team
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  • Creating a Holistic Extractables and Leachables (E&L) Program for Biotechnology Products
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Review

  • A Risk Assessment and Risk-Based Approach Review of Pre-Use/Post-Sterilization Integrity Testing (PUPSIT)
  • Recommendations for Artificial Intelligence Application in Continued Process Verification: A Journey Toward the Challenges and Benefits of AI in the Biopharmaceutical Industry
  • A Review of Artificial Intelligence and Machine Learning in Product Life Cycle Management
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Keywords

  • Extractables
  • Leachables
  • Safety assessment
  • Safety qualification thresholds
  • parenteral and ophthalmic drug products
  • Best practice recommendations
  • Biologic concerns
  • PQRI
  • Parenteral packaging
  • Ophthalmic containers

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© 2025 PDA Journal of Pharmaceutical Science and Technology Print ISSN: 1079-7440  Digital ISSN: 1948-2124

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