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United States Pharmacopeia (USP) : Laboratory Proficiency Testing Program

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

EPTIS Ringversuch Nr. 886966 | Letze Änderung 2023-04-14 | URL: https://www.eptis.bam.de/pts886966 https://www.eptis.bam.de/pts886966

Name des Anbieters
Name des Anbieters United States Pharmacopeia Convention United States Pharmacopeia Convention
Ansässig in United States
Sprache(n) English
Anmerkungen 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
Klassifizierung
Produktgruppen Cosmetics
Food and drink
Laboratory / scientific equipment
Pharmaceutical products, drugs
Plants
Water
Prüfgebiete Analytical chemistry
Biology
Microbiology
Technische Einzelheiten
Prüfobjekt Prüfeigenschaft Prüfmethode
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 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>
Alcohol Determination USP <611>
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>
Loss on Ignition USP <733>
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>
Water Activity USP <922>
Microbiology Microbial enumeration USP <2021>
Microbiological Analysis - Identification USP <2022>
Microbial examination USP <2023>
Ringversuchsziele
Zielgruppe des Ringversuchs Testing Laboratories required to demonstrate proficiency for samples designed in correlation to the USP General Chapters, WHO-TRS, ICH Q4A-Q4B, Q7 (3.12), Q9, Q10, CFR 211.25 and additionally harmonized validated methods. / USP follows trade compliance regulations of the US.
Relevante Rechtsvorschriften oder Normen Technical Standard: ISO/IEC 17025:2017 Technical Standard: ISO/IEC 17043:2010 WHO- Prequalification Program
Weitere Ziele Strengthen competency of lab analyst, staff training support, laboratory continuous improvement, QMS capacity building.
Teilnehmerzahl >35 per study
Anbieter unabhängig überprüft (akkreditiert, benannt, anerkannt)

Akkreditiert durch ANAB auf der Grundlage von 17043:2010 Conformity assessment- General requirements for proficiency testing

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

Die Durchführung des Ringversuchs ist in Auftrag gegeben durch
Kosten
Teilnahmegebühr For the cost of specific test- See: https://www.nsilabsolutions.com/product-category/usp-pt-program/
Regelmässig durchgeführt Ja (3X Year)
Der Ringversuch wird durchgeführt seit 2021
Kontaktdaten des Anbieters
Anbieter Kontaktperson
United States Pharmacopeia Convention
12601 twinbrook pwky
Rockville
United States

Telefon: 3012303240
Fax: N/A
Web: https://www.usp.org/ https://www.usp.org/
PT Administrator
Telefon: 3012303240
Fax: N/A
E-Mail: PTProgram@usp.org PTProgram@usp.org
Haben Sie einen Fehler entdeckt? Bitte wenden Sie sich an den zuständigen EPTIS Koordinator für United States, Dr. George W. Latimer, Jr.. Dr. George W. Latimer, Jr..
Haben Sie Fragen? Senden Sie uns eine E-Mail: eptis@bam.de.
Anwendungsversion: 1.23-SNAPSHOT.20230502124635-7925ae379a631fc1ececff45d2921c8db38877d5