PT - JOURNAL ARTICLE AU - Dennis E. Guilfoyle AU - Anthony M. Cundell TI - Do Plant Isolates have a Role in Method Suitability and Growth Promotion Testing in the Microbiology Laboratory? Is it a Matter of Science versus Compliance? AID - 10.5731/pdajpst.2021.012675 DP - 2022 Jan 01 TA - PDA Journal of Pharmaceutical Science and Technology PG - pdajpst.2021.012675 4099 - http://journal.pda.org/content/early/2022/02/15/pdajpst.2021.012675.short 4100 - http://journal.pda.org/content/early/2022/02/15/pdajpst.2021.012675.full AB - 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 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.