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PDA Journal of Pharmaceutical Science and Technology

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Research ArticlePDA Papers

PDA Points to Consider: Best Practices for Document/Data Management and Control and Preparing for Data Integrity Inspections

Deb Autor, Zena Kaufman, Ron Tetzlaff, Maryann Gribbin, Madlene Dole, Derek Glover, Brad Mercer, Doreen Newhouse, Jackie Veivia-Panter, Anil Sawant and Denyse Baker
PDA Journal of Pharmaceutical Science and Technology May 2018, 72 (3) 332-337; DOI: https://doi.org/10.5731/pdajpst.2018.008573
Deb Autor
Mylan
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  • For correspondence: deborah.autor@mylan.com
Zena Kaufman
ZGK Quality Consulting
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Ron Tetzlaff
PAREXEL International
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Maryann Gribbin
Faith and Royale Consultants
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Madlene Dole
Novartis
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Derek Glover
Mylan
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Brad Mercer
Avantor Inc.
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Doreen Newhouse
Bridge Associates International LLC
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Jackie Veivia-Panter
Celgene
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Anil Sawant
Merck
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Denyse Baker
PDA
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In This Issue

PDA Journal of Pharmaceutical Science and Technology: 72 (3)
PDA Journal of Pharmaceutical Science and Technology
Vol. 72, Issue 3
May/June 2018
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PDA Points to Consider: Best Practices for Document/Data Management and Control and Preparing for Data Integrity Inspections
Deb Autor, Zena Kaufman, Ron Tetzlaff, Maryann Gribbin, Madlene Dole, Derek Glover, Brad Mercer, Doreen Newhouse, Jackie Veivia-Panter, Anil Sawant, Denyse Baker
PDA Journal of Pharmaceutical Science and Technology May 2018, 72 (3) 332-337; DOI: 10.5731/pdajpst.2018.008573

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PDA Points to Consider: Best Practices for Document/Data Management and Control and Preparing for Data Integrity Inspections
Deb Autor, Zena Kaufman, Ron Tetzlaff, Maryann Gribbin, Madlene Dole, Derek Glover, Brad Mercer, Doreen Newhouse, Jackie Veivia-Panter, Anil Sawant, Denyse Baker
PDA Journal of Pharmaceutical Science and Technology May 2018, 72 (3) 332-337; DOI: 10.5731/pdajpst.2018.008573
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  • Article
    • Abstract
    • Background and Purpose
    • Question 1: Copies of Good Manufacturing Practice (GMP) Records
    • Question 2: Documents Not Traditionally Considered GMP Records
    • Question 3: Personal Diaries
    • Question 4: Drafts of GMP Documents
    • Question 5: E-mails as GMP Records
    • Question 6: Business Records That Are Not GMP Records
    • Question 7: Use of Shredders
    • Question 8: Retention of Closed Circuit Television (CCTV)
    • Question 9: Data Capture Capabilities
    • Question 10: Quality Plans
    • Question 11: Questioning Investigator Actions in the Field
    • Conclusion
    • Conflict of Interest Statement
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  • References
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More in this TOC Section

  • Achieving “Zero” Defects for Visible Particles in Injectables
  • Demonstrating Pharmaceutical Quality System Effectiveness and Driving Continual Improvement: Evidence-Based Risk Reduction
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