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EditorialGuest Editorial

Lessons from a Pandemic: Maintaining Compliant GxP Surveillance Programs and Stable Pharmaceutical Supply

Jose Caraballo and Fenton Fong
PDA Journal of Pharmaceutical Science and Technology November 2020, 74 (6) 612-616; DOI: https://doi.org/10.5731/pdajpst.2020.012518
Jose Caraballo
Bayer, Pittsburgh, PA
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  • For correspondence: jose.caraballo@bayer.com
Fenton Fong
xCellarate Technology Consulting Inc., Vancouver, Canada
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References

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    Determination that a Public Health Emergency Exists, 2020. U.S. Department of Health and Human Services Public Health Emergency Web site. https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx (accessed September 28, 2020).
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    Guidance for Industry -Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products. FDA CDER, 2011. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/planning-effects-high-absenteeism-ensure-availability-medically-necessary-drug-products-0.
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    Medicines and Healthcare products Regulatory Agency. MHRA Regulatory Flexibilities Resulting from Coronavirus (COVID-19), 2020. GOV.UK Web site. https://www.gov.uk/guidance/mhra-regulatory-flexibilities-resulting-from-coronavirus-covid-19 (accessed September 28, 2020).
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    Drug Shortages. FDA Website, 2020. https://www.fda.gov/drugs/drug-safety-and-availability/drug-shortages (accessed October 2, 2020).
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    1. Zhang D
    , FDA data shows numerous drugs in shortage, including a leading antidepressant. USA TODAY [Online]. June 10, 2020. https://www.usatoday.com/story/news/2020/06/10/coronavirus-and-fda-drug-shortage-list/5330491002/ (accessed October 2, 2020).
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    1. Cundell T.,
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    Controls to Minimize Disruption of the Pharmaceutical Supply Chain during the COVID-19 Pandemic. PDA J. Pharm. Sci. Technol. [Online] 2020, 74 (4), 468–494. https://journal.pda.org/content/74/4/468 (accessed September 28, 2020).
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    1. Rönninger S.,
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    Considerations on Auditing and GxP Requirements along the Product Lifecycle. PDA J. Pharm. Sci. Technol. 2012, 66 (5), 396–402.
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    Parenteral Drug Association Inc. PDA Standard 001-2020, Enhanced Purchasing Controls to Support the Bio-Pharmaceutical, Pharmaceutical, Medical Devices and Combination Products Industries; Bethesda, MD, 2020.
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In This Issue

PDA Journal of Pharmaceutical Science and Technology: 74 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 74, Issue 6
November/December 2020
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Lessons from a Pandemic: Maintaining Compliant GxP Surveillance Programs and Stable Pharmaceutical Supply
Jose Caraballo, Fenton Fong
PDA Journal of Pharmaceutical Science and Technology Nov 2020, 74 (6) 612-616; DOI: 10.5731/pdajpst.2020.012518

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Lessons from a Pandemic: Maintaining Compliant GxP Surveillance Programs and Stable Pharmaceutical Supply
Jose Caraballo, Fenton Fong
PDA Journal of Pharmaceutical Science and Technology Nov 2020, 74 (6) 612-616; DOI: 10.5731/pdajpst.2020.012518
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    • Impact on Good Practice Surveillance Programs during Crises
    • Disruption of Supply Chains
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More in this TOC Section

  • Assessment of Extractable and Leachable Substances from Pharmaceutical Contact Materials: Where Are We and Where Do We Go from Here?
  • Scientific Studies and Interpretation
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