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- Published online October 3, 2022.
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- previous version (February 15, 2022 - 08:07).
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© PDA, Inc. 2022
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- 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
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