USP Proficiency Testing ProgramUSP PT Schemes

USP <71> Sterility Proficiency Test




Catalog Number:
Choose Study Number

PH-0921, PH-0122, PH-0422

Product Details

Product Details

Proficiency Test for laboratories testing pharmaceutical materials for the presence or absence of specified microorganisms in accordance with USP 71.  A five vial sample panel with three POSITIVE (non-sterile) and two NEGATIVE (sterile) containing organisms of interest at appropriate levels for USP <71>. The panel contains five single-pellet vials, three positive sample pellets containing Staphylococcus aureus, Bacillus subtilis, Pseudomonas aeruginosa, Candida albicans, or Aspergillus brasiliensis. as well as Two blank pellets. The panel also includes five 5mL vials of sterile peptone buffer. Participants will identify which samples meet the sterility test requirements per the USP monograph.

USP PT Schedule

USP PT Schedule

Study Number Study Open Date Study Close Date
PH-0422 4/18/2022 07/15/2022*

Extended from 6/9/22

PH-0922 9/19/2022 11/18/2022
PH-0123 1/16/2023 3/17/2023
PH-0523 5/15/2023 6/14/2023



USP Harmonized Compendial Methods

USP Harmonized Compendial Methods


United States Pharmacopeia (USP) Ph. Eur, EP JP NSI Catalog Item Harmonized Description


 USP  <61>
Microbiological Examination of Non-sterile Products




JP <35> Microbial Limit Test




Microbial Enumeration of Non-sterile Products


USP <62>

Microbiological Examination of Non-sterile Products: Tests for Specified Microorganisms




JP <35> Microbial Limit Test




Test for Specified Microorganisms in Non-sterile Products


USP <71>

Sterility Testing




JP <4.06>




Sterility Test


USP <51>

Antimicrobial Effectiveness Testing




JP <19>




Preservative Efficacy Test