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PDA Journal of Pharmaceutical Science and Technology

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Research ArticleTechnology/Application

Evaluation of the Microbial Growth Potential of Pharmaceutical Drug Products and Quality by Design

Anastasia G. Lolas and John W. Metcalfe
PDA Journal of Pharmaceutical Science and Technology January 2011, 65 (1) 63-70;
Anastasia G. Lolas
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  • For correspondence: anastasia.lolas@fda.hhs.gov
John W. Metcalfe
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Abstract

The microbial growth potential of a pharmaceutical drug product refers to the ability of microorganisms to survive and proliferate in the product. Each drug formulation possesses a different potential for supporting or inhibiting microbial growth. Understanding this microbial growth potential can have a significant effect on the development and design of the drug manufacturing process. This article describes how this attribute can exert this effect on manufacturing process development and design through real examples and case studies obtained from the regulatory review of new drug and biologics license applications. In addition, this article describes how understanding the microbial growth potential of a pharmaceutical drug product is an element of the Quality by Design paradigm and how this understanding can simplify the drug development process and lead to better process design.

LAY ABSTRACT: The microbial growth potential of a pharmaceutical drug product refers to the ability of microorganisms to survive and proliferate in the product formulation. Each drug product formulation possesses a different potential for supporting or inhibiting microbial growth depending on its components. Understanding this microbial growth potential can have a significant effect on the development and design of the drug manufacturing process. This article describes how this attribute can affect manufacturing process development and design through real examples and case studies obtained from the regulatory review of new drug and biologics license applications. In addition, this article describes how understanding the microbial growth potential of a pharmaceutical drug product is an element of the Quality by Design paradigm and how this understanding can simplify the drug development process and lead to better process design.

  • Quality by Design
  • QbD
  • Microbial growth
  • Pharmaceuticals
  • Water activity
  • New drug application
  • Biologics license application
  • ©PDA, Inc. 2011
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PDA Journal of Pharmaceutical Science and Technology: 65 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 65, Issue 1
January/February 2011
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Evaluation of the Microbial Growth Potential of Pharmaceutical Drug Products and Quality by Design
Anastasia G. Lolas, John W. Metcalfe
PDA Journal of Pharmaceutical Science and Technology Jan 2011, 65 (1) 63-70;

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Evaluation of the Microbial Growth Potential of Pharmaceutical Drug Products and Quality by Design
Anastasia G. Lolas, John W. Metcalfe
PDA Journal of Pharmaceutical Science and Technology Jan 2011, 65 (1) 63-70;
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  • Article
    • Abstract
    • Introduction
    • Microbial Growth Studies
    • Water Activity as a Tool for Evaluating the Microbial Growth Potential of Nonsterile Pharmaceutical Dosage Forms
    • Sterile Pharmaceutical Dosage Forms
    • Microbial Growth Potential and QbD—Examples and Case Studies
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