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PDA Journal of Pharmaceutical Science and Technology

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OtherPDA Paper

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

Deborah M. 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 February 2018, pdajpst.2018.008573; DOI: https://doi.org/10.5731/pdajpst.2018.008573
Deborah M. Autor
Mylan;
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  • For correspondence: debautor1@gmail.com
Zena Kaufman
Roivant Pharmaceuticals;
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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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Abstract

PDA has identified eleven current questions related to data management and control that have been frequently cited in FDA Inspections or have led to FDA regulatory actions. The purpose of this document is to help to clarify some of these issues for industry and to help facilitate better compliance by sharing PDA members' expertise in and understanding of current best practices.

  • Best Practices
  • Data Integrity
  • Document Control
  • Document Management
  • Inspections
  • Received January 15, 2018.
  • Accepted January 21, 2018.
  • Copyright © 2018, Parenteral Drug Association
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In This Issue

PDA Journal of Pharmaceutical Science and Technology: 73 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 73, Issue 6
November/December 2019
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PDA Points to Consider: Best Practices for Document/Data Management and Control and Preparing for Data Integrity Inspections
Deborah M. 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 Feb 2018, pdajpst.2018.008573; 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
Deborah M. 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 Feb 2018, pdajpst.2018.008573; DOI: 10.5731/pdajpst.2018.008573
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More in this TOC Section

  • Points to Consider: Best Practices to Identify Particle Entry Routes along the Manufacturing Process for Parenteral Formulations
  • Solving the Global Continual Improvement and Innovation Challenge: How an Effective Pharmaceutical Quality System Can Transform Post-Approval Change Management
  • PDA PAC iAM 2017 Survey on Post Approval Change: Is the Regulatory Environment Hindering Much-Needed Innovation in the Pharma Industry?
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Keywords

  • Best Practices
  • Data Integrity
  • Document Control
  • Document Management
  • Inspections

 

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