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Quality Control - Pharmceuticals products

[Control de Calidad - Productos farmacéuticos ]

EPTIS Ringversuch Nr. 594330 | Letze Änderung 2020-01-07 | URL: https://www.eptis.bam.de/pts594330 https://www.eptis.bam.de/pts594330

Name des Anbieters
Name des Anbieters Comité de Ensayos Interlaboratorios del Instituto Nacional de Salud Comité de Ensayos Interlaboratorios del Instituto Nacional de Salud
Ansässig in Peru
Sprache(n) English and Spanish
Anmerkungen The Interlaboratory Testing Committee of the National Institute of Health of Lima-Peru invites you to participate in the 2019 Fitness Test Round - Pharmaceutical Sector according to the attached Program. It should be noted that the National Institute of Health constitutes the INS Interlaboratory Testing Committee in 2011 with RJ N ° 069-2011-J-OPE / INS and reconforms it in 2015 with RJ N ° 041-2015-J-OPE / INS, which aims to conduct, plan, organize, and coordinate the execution of interlaboratory tests in the INS, at national and / or international level, in food quality control, diagnosis of infectious diseases and quality control of pharmaceutical products , medical devices and medical devices, for which it is implementing the international standard ISO / IEC 17043 Conformity assessment - General requirements for proficiency testing. In the proficiency tests organized since 2011, laboratories from Peru (Network of laboratories and 15 manufacturing laboratories) and from sister countries such as Bolivia, Chile, Uruguay, Ecuador, Colombia, Brazil (up to 12 states), El Salvador, Mexico have participated , Panama, Guyana, Jamaica, Cuba, Guatemala and Costa Rica. https://web.ins.gob.pe/es/acerca-del-ins/comites-del-ins/comite-ensayos-interlaboratorios
Klassifizierung
Produktgruppen Pharmaceutical products, drugs
Prüfgebiete Analytical chemistry
Biology
Microbiology
Technische Einzelheiten
Prüfobjekt Prüfeigenschaft Prüfmethode
Pharmaceutical products pH USP 42
Antibiotics - Microbial Assay USP 42
Spectrophotometry: UV/VIS USP 42
Microbiological Examination of non sterile products: Microbial enumeration test USP 42
Microbiological Examination of non sterile products: tests for specified micoorganis USP 42
Sterility testing USP 42
Bacterial endotoxins (LAL Gel Clot) USP 42
Chromatography: HPLC USP 42
Weight -Consistency of Formulated Preparations, Uniformity of weight British Pharmacopeia, App. XIIC Consistency of Formulated Preparations
Determination of Volume USP 42
Specific Gravity USP 42
Uniformity of Dosage Units USP 42
Dissolution USP 42
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Ringversuchsziele
Zielgruppe des Ringversuchs Pharmaceutical laboratories
Relevante Rechtsvorschriften oder Normen United States Pharmacopoeia
Weitere Ziele use instrucctions
Teilnehmerzahl 30
Anbieter unabhängig überprüft (akkreditiert, benannt, anerkannt)

National Institute of Health of Peru

Die Durchführung des Ringversuchs ist in Auftrag gegeben durch No
Kosten
Teilnahmegebühr 390 USD
Regelmässig durchgeführt Ja (annual)
Der Ringversuch wird durchgeführt seit 2011
Kontaktdaten des Anbieters
Anbieter Kontaktperson
Comité de Ensayos Interlaboratorios del Instituto Nacional de Salud

51
Peru

Telefon: 975148486
Fax:
Web: http://web.ins.gob.pe/es/acerca-del-ins/comites-del-ins/comite-ensayos-interlaboratorios http://web.ins.gob.pe/es/acerca-del-ins/comites-del-ins/comite-ensayos-interlaboratorios
Biologo Fernando Alva
Telefon: 975148486
Fax:
E-Mail: falva@ins.gob.pe falva@ins.gob.pe
Haben Sie einen Fehler entdeckt? Bitte wenden Sie sich an den zuständigen EPTIS Koordinator für Peru, Mr José Ricardo Bardellini da Silva. Mr José Ricardo Bardellini da Silva.
Haben Sie Fragen? Senden Sie uns eine E-Mail: eptis@bam.de.
Anwendungsversion: 1.23-SNAPSHOT.20230502124635-7925ae379a631fc1ececff45d2921c8db38877d5