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United States Pharmacopeia (USP) : Laboratory Proficiency Testing Program

[United States Pharmacopeia (USP) : Laboratory Proficiency Testing Program]

EPTIS factsheet 886966 | Last revision 2022-06-02 | URL: https://www.eptis.bam.de/pts886966 https://www.eptis.bam.de/pts886966

PT provider
PT provider United States Pharmacopeia Convention United States Pharmacopeia Convention
Based in United States
Language(s) English
Remarks The USP Proficiency Testing program is in affiliation with NSI Lab Solutions a subsidiary of Antylia. NSI lab solutions maintains the ANAB accreditation for ISO 17034 and ISO 17043 in support of the PT program. Contact the USP PT program at PTProgram@usp.org
Keywords
Product groups Cosmetics
Food and drink
Laboratory / scientific equipment
Pharmaceutical products, drugs
Plants
Water
Testing fields Analytical chemistry
Biology
Microbiology
Technical details
Test item Tested property Testing method
Microbiology Antimicrobical Susceptibility USP <51>
Microbiological Examination of non sterile products: tests for specified micoorganis USP <60>
Microbial enumeration USP <61>
Bioburden USP <61> & <62>
Microbial examination USP <62>
Sterility USP <71>
Biological material Antibiotics - Microbial Assay USP <81>
Bacterial endotoxins (LAL Gel Clot) USP <85>
Pharmaceutical products (Powders or liquids) - Basic chemical analysis UV Spectroscopy USP <197>
USP <197u>
Pharmaceutical products (powders or liquids) - Advanced chemical analysis Impurities determination USP <233>
Pharmaceutical products (Powders or liquids) - Basic chemical analysis Residue on ignition (ROI) USP <281>
Pharmaceutical products (powders or liquids) - Advanced chemical analysis Residual Solvents USP <467>
Pharmaceutical products (Powders or liquids) - Basic chemical analysis Potentionmetric Titration USP <541>
Colorimetry, specular gloss, wettability USP <541>
Pharmaceutical products High Performance Liquid Chromatography (HPLC) USP <621>
Pharmaceutical products (powders or liquids) - Advanced chemical analysis High Performance Liquid Chromatography (HPLC) USP <621>
Pesticide formulation Gas Chromatography- ECD USP <621>
Pharmaceutical products (powders or liquids) - Advanced chemical analysis Gas Chromatography- FID USP <621>
Pharmaceutical products (Powders or liquids) - Basic chemical analysis Conductivity USP <644>
Pharmaceutical products Disintegration USP <701>
Dissolution USP <711>
Pharmaceutical products (Powders or liquids) - Basic chemical analysis Loss on Drying USP <731>
Pharmaceutical products (powders or liquids) - Advanced chemical analysis Gas Chromatography- MS USP <736>
NMR (Qualitative or Quantitative) USP <761>
Pharmaceutical products (Powders or liquids) - Basic chemical analysis Optical rotation USP <781>
PH USP <791>
Pharmaceutical products - Sterility tests Compounding USP <797>
Pharmaceutical products (Powders or liquids) - Basic chemical analysis Refractive Index USP <831>
Pharmaceutical products Uniformity of Dosage Units USP <905>
Pharmaceutical products (Powders or liquids) - Basic chemical analysis Water Determination USP <921>
Microbiology Microbial enumeration USP <2021>
Microbiological Analysis - Identification USP <2022>
Microbial examination USP <2023>
Aims of the PT scheme
Target group of participants Testing Laboratories required to demonstrate proficiency for samples designed in correlation to the USP General Chapters, ICH Q4A-Q4B, Q7 (3.12), Q9, Q10, CFR 211.25 and additionally harmonized validated methods. / USP follows trade compliance regulations of the US.
Linked to specific legislation / standards Technical Standard: ISO/IEC 17025:2017 Technical Standard: ISO/IEC 17043:2010 WHO- Prequalification Program
Additional, subsidiary aims Strengthen competency of lab analyst, staff training support, laboratory continuous improvement, QMS capacity building.
Number of participants >35 per study
Accredited or otherwise reviewed by a 3rd party

Accredited by ANAB on the basis of 17043:2010 Conformity assessment- General requirements for proficiency testing

In conjunction via a third party for Operation. NSI Lab Solution Inc.

Operation is commissioned / requested by
Fees and frequency
Participation fee For the cost of specific test- See: https://www.nsilabsolutions.com/product-category/usp-pt-program/
Regularly operated Yes (3X Year)
Year of first operation 2021
Contact details of the PT provider
Provider Contact person
United States Pharmacopeia Convention
12601 twinbrook pwky
Rockville
United States

Phone: 3012303240
Fax: N/A
Web: https://www.usp.org/ https://www.usp.org/
Donnell Charles
Phone: 3012303240
Fax: N/A
Email: PTProgram@usp.org PTProgram@usp.org
If you find any mistakes please contact the responsible EPTIS coordinator in United States, Dr. George W. Latimer, Jr.. Dr. George W. Latimer, Jr..
Any questions or problems? Please contact us at eptis@bam.de.
Application version: 1.21