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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Table of Contents:
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Detailed Table of ContentsIntroduction
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