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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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Abstract

The Parenteral Drug Association (PDA) has identified 11 current questions related to data management and control that have been frequently cited in U.S. Food and Drug Administration (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.

Data integrity inspectional observations by health authorities can have a severe impact on a firm from a regulatory and public perception perspective and should not result from a lack of clarity by industry about what is required. In addition, firms are concerned that the inability to produce a requested record or document during an inspection, even if not a standard report or existing quality system document, could be construed as delaying, denying, limiting, or refusing inspection, which also has significant consequences.

The PDA acknowledges it may not be possible for a single firm or site to have a meaningful discussion of these issues in the context of an inspection or inspection response and is offering these best practices so that industry can proactively comply and properly prioritize its efforts to improve document management and control and good manufacturing practices in the most efficient and effective means possible. The PDA acknowledges there are many more questions to be addressed and hopes that there can be an ongoing dialogue between industry and regulators to facilitate answers.

  • © PDA, Inc. 2018
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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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