PDA Survey: 2013 PDA Objectionable Microorganisms for Nonsterile Pharmaceutical, Consumer Health, Medical Devices, Dietary Supplement and Cosmetic Products (single user digital version)

Jan 2014
PDA Item Number

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This benchmarking survey was designed to facilitate the development of a technical report on exclusion of objectionable microorganisms from pharmaceutical and over-the-counter drug products, medical devices and cosmetics. The purpose of this survey was to evaluate how different companies and industries are handling the issue of objectionable microorganisms in nonsterile finished product formulations.

The survey team distributed the survey to the PDA membership, to the members of the Pharmaceutical Microbiology Forum Listserv (PMFList), and to colleagues throughout the pharmaceutical and other consumer product industries.

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Format: PDF (1 file 2.15 MB)

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Table of Contents

Table of Contents:

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  • Introduction
  • General Demographics
  • Microbial Testing of Nonsterile Product Formulations
  • Purified Water Systems
  • Cleaning and Sanitization of Nonsterile Manufacturing Equipment
  • Microbial Content Test Methods
  • Rapid Microbial Test Methods
  • Identification Test Methods of Recovered Microbial Isolates
  • Microbial Acceptance Criteria For Nonsterile Finished Product Formulations
  • Types of Microorganism Considered As Objectionable in Nonsterile Product Formulations
  • Risk Factors Analysis
  • Microbial Test Specifications
  • Steps Taken in Preventing the Isolation of Objectionable Microorganisms
  • Feedback From Survey Respondents Concerning Which Microbial Species Could Be Considered As Objectionable For Their Company Produced Nonsterile Finished Product Formulations