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PDA Journal of Pharmaceutical Science and Technology

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Review ArticleReview

Microbiological Test Data—Assuring Data Integrity

Edward C. Tidswell and Tim Sandle
PDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 2-14; DOI: https://doi.org/10.5731/pdajpst.2017.008151
Edward C. Tidswell
Executive Director, Merck, West Point, PA 19486
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  • For correspondence: Edward.tidswell@merck.com
Tim Sandle
Executive Director, Merck, West Point, PA 19486
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Article Information

vol. 72 no. 1 2-14
DOI 
https://doi.org/10.5731/pdajpst.2017.008151
PubMed 
29030529

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online January 30, 2018.

Article Versions

  • previous version (October 12, 2017 - 19:14).
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Copyright & Usage 
© PDA, Inc. 2018

Author Information

  1. Edward C. Tidswell* and
  2. Tim Sandle
  1. Executive Director, Merck, West Point, PA 19486
  1. ↵* Corresponding Author: Executive Director, Merck, West Point, PA 19486. Telephone 224-931-9059; e-mail: Edward.tidswell@merck.com
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  • Case study on the environmental monitoring for biological manufacturing using Time-lapse Shadow Image Analysis
    Shoji Narutaki, Ineui Lee, Yasuhito Sugawara, Kahei Akada, Akihiko Kondo
    Biologicals 2020 66
  • Study of contact plates recovery from pharmaceutical cleanroom surfaces across three-time ranges
    Tim Sandle
    EJPPS EUROPEAN JOURNAL OF PARENTERAL AND PHARMACEUTICAL SCIENCES 2020
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In This Issue

PDA Journal of Pharmaceutical Science and Technology: 72 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 72, Issue 1
January/February 2018
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Microbiological Test Data—Assuring Data Integrity
Edward C. Tidswell, Tim Sandle
PDA Journal of Pharmaceutical Science and Technology Jan 2018, 72 (1) 2-14; DOI: 10.5731/pdajpst.2017.008151
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  • Article
    • Abstract
    • Introduction
    • Microbial Quality Attributes
    • QC Microbiological Tests
    • Strategies for Assuring Microbiological Data Integrity
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    • Conflict of Interest Declaration
    • Reference
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More in this TOC Section

  • The Role of Microbiologists in Drug Product Development
  • A Risk Assessment and Risk-Based Approach Review of Pre-Use/Post-Sterilization Integrity Testing (PUPSIT)
  • Recommendations for Artificial Intelligence Application in Continued Process Verification: A Journey Toward the Challenges and Benefits of AI in the Biopharmaceutical Industry
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Keywords

  • Microbiological tests
  • Data integrity
  • Microbiological quality attributes
  • Sterility test
  • Bioburden test

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Microbiological Test Data—Assuring Data Integrity
Edward C. Tidswell, Tim Sandle
PDA Journal of Pharmaceutical Science and Technology Jan 2018, 72 (1) 2-14; DOI: 10.5731/pdajpst.2017.008151

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