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Research ArticlePDA Papers

PDA Points to Consider: Technical Product Lifecycle Management. Pharmaceutical Quality System Effectiveness for Managing Post-approval Changes

Authors: Members of the PDA Task Force on Post-approval Changes for Innovation in Availability of Medicines (PAC iAMsm), Emma Ramnarine, Ursula Busse, Marcello Colao, Julia Edwards, Kevin O'Donnell, Maik Jornitz, Morten Munk, Melissa Seymour, Mihaela Simianu, Lisa Skeens and Anders Vinther
PDA Journal of Pharmaceutical Science and Technology May 2017, 71 (3) 252-258; DOI: https://doi.org/10.5731/pdajpst.2017.007575
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Emma Ramnarine
Genentech
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  • For correspondence: eramnar@gene.com
Ursula Busse
Novartis
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Marcello Colao
GlaxoSmithKline Biologicals
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Julia Edwards
Biogen
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Kevin O'Donnell
Health Products Regulatory Authority (HPRA), Ireland
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Maik Jornitz
G-Con, LLC
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Morten Munk
NNE Pharmaplan
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Melissa Seymour
Biogen
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Mihaela Simianu
Pharmatech Associates
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Lisa Skeens
Pfizer
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Anders Vinther
Sanofi-Pasteur
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Reference

  1. 1.↵
    Quality Guideline Q10: Pharmaceutical Quality System; International Conference on Harmonisation: Geneva, Switzerland, 2008 [http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html (accessed August 28, 2016)].
  2. 2.↵
    PDA Points to Consider: Technical Product Lifecycle Management: Communication and Knowledge Exchange between Marketing Authorization Holders and Health Authorities. PDA J. Pharm. Sci. Technol. (accepted article January 2017) [journal.pda.org (accessed January 23, 2017)].
  3. 3.↵
    Quality Guideline Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management, concept paper and business plan; ICH: Geneva, 2014.
  4. Concept paper: [http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q12/Q12_Final_Concept_Paper_July_2014.pdf (accessed December 2016)].
  5. Business plan: [http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q12/Q12_Final_Buisness_Plan_July_2014.pdf (accessed December 2016)].
  6. 4.↵
    White Paper: FDA Pharmaceutical Quality Oversight, One Quality Voice; Office of Pharmaceutical Quality, U.S. Food and Drug Administration, U.S. Government Printing Office: Washington, DC, 2015 [http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM442666.pdf (accessed January 6, 2017)].
  7. 5.↵
    Final Report on Pharmaceutical cGMPs for the 21st Century—A Risk Based Approach; U.S. Food and Drug Administration, September, 2004 [http://www.fda.gov/downloads/drugs/developmentapprovalprocess/manufacturing/questionsandanswersoncurrentgoodmanufacturingpracticescgmpfordrugs/ucm176374.pdf (accessed January 23, 2017].
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PDA Journal of Pharmaceutical Science and Technology: 71 (3)
PDA Journal of Pharmaceutical Science and Technology
Vol. 71, Issue 3
May/June 2017
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PDA Points to Consider: Technical Product Lifecycle Management. Pharmaceutical Quality System Effectiveness for Managing Post-approval Changes
Authors: Members of the PDA Task Force on Post-approval Changes for Innovation in Availability of Medicines (PAC iAMsm), Emma Ramnarine, Ursula Busse, Marcello Colao, Julia Edwards, Kevin O'Donnell, Maik Jornitz, Morten Munk, Melissa Seymour, Mihaela Simianu, Lisa Skeens, Anders Vinther
PDA Journal of Pharmaceutical Science and Technology May 2017, 71 (3) 252-258; DOI: 10.5731/pdajpst.2017.007575

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PDA Points to Consider: Technical Product Lifecycle Management. Pharmaceutical Quality System Effectiveness for Managing Post-approval Changes
Authors: Members of the PDA Task Force on Post-approval Changes for Innovation in Availability of Medicines (PAC iAMsm), Emma Ramnarine, Ursula Busse, Marcello Colao, Julia Edwards, Kevin O'Donnell, Maik Jornitz, Morten Munk, Melissa Seymour, Mihaela Simianu, Lisa Skeens, Anders Vinther
PDA Journal of Pharmaceutical Science and Technology May 2017, 71 (3) 252-258; DOI: 10.5731/pdajpst.2017.007575
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  • Article
    • Introduction
    • Background
    • PQS Effectiveness for Post-approval Changes
    • Measuring PQS Effectiveness
    • The Role of Quality Culture in Enabling PQS Effectiveness
    • Conclusion
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    • Conflict of Interest Declaration
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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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