RT Journal Article
SR Electronic
T1 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?
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 444
OP 460
DO 10.5731/pdajpst.2021.012675
VO 76
IS 5
A1 Dennis E. Guilfoyle
A1 Anthony M. Cundell
YR 2022
UL http://journal.pda.org/content/76/5/444.abstract
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 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.