Abstract
In response to regulatory citations for not including plant isolates in method suitability and growth promotion testing of microbiological culture media, the authors make the case that the compendial designated cultures meet the requirements of the official tests and are sufficiently representative of the most frequently identified environmental isolates. It was our conclusion that this compliance request lacks scientific justification. The scope of this review was largely directed to the growth promotion and suitability testing requirements for USP <60>, <61>, <62>, and <71>. Other microbiological tests such as USP <51> Antimicrobial Effective Testing, media fill validation, and water and environmental monitoring are discussed.
- Plant isolates
- Compendial designated cultures
- Method suitability
- Growth promotion
- Microbial tests
- 483 observations
- Warning letters
- © PDA, Inc. 2022
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In This Issue
Jump to section
- Article
- Abstract
- Introduction
- Origin of the Use of Plant Isolates for Method Qualification and Growth Promotion Testing
- Support for the Use of Plant Isolates in Other Regulatory Documents
- The Instability of Plant Isolates in QC Laboratories
- The Authority Given to the USP as a U.S. Standard-Setting Organization in the U.S. Federal Food, Drug, and Cosmetics Act
- USP Requirements for Method Suitability and Growth Promotion Testing in USP <60>, <61>, <62>, and <71>
- Experience in Clinical Microbiology Related to Growth Promotion Testing
- History of Citation of the Absence of the Use of Plant Isolates during Regulatory Inspections
- Why Are These Citations Misguided?
- Microbial Species Most Frequently Isolated during Environmental and Water Monitoring and Product Release Testing
- What Are the Phenotypic and Genotypic Differences between Compendial Strains and Plant Isolates?
- The Role of Plant Isolates in Formulation Development—Especially Preservative Effectiveness Testing
- Relationship between Compendial Designated Strains and Common Plant Isolates
- Common Plant Isolates from Pharmaceutical Environments
- What Are the Growth Promotion Tests Used by Media Manufacturers?
- Conclusions
- Conflict of Interest Declaration
- Acknowledgements
- References
- Figures & Data
- References
- Info & Metrics