EPTIS
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Quality Control - Pharmceuticals products

[Control de Calidad - Productos farmacéuticos ]

EPTIS factsheet 594330 | Last revision 2020-01-07 | URL: https://www.eptis.bam.de/pts594330 https://www.eptis.bam.de/pts594330

PT provider
PT provider Comité de Ensayos Interlaboratorios del Instituto Nacional de Salud Comité de Ensayos Interlaboratorios del Instituto Nacional de Salud
Based in Peru
Language(s) English and Spanish
Remarks 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
Keywords
Product groups Pharmaceutical products, drugs
Testing fields Analytical chemistry
Biology
Microbiology
Technical details
Test item Tested property Testing method
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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Aims of the PT scheme
Target group of participants Pharmaceutical laboratories
Linked to specific legislation / standards United States Pharmacopoeia
Additional, subsidiary aims use instrucctions
Number of participants 30
Accredited or otherwise reviewed by a 3rd party

National Institute of Health of Peru

Operation is commissioned / requested by No
Fees and frequency
Participation fee 390 USD
Regularly operated Yes (annual)
Year of first operation 2011
Contact details of the PT provider
Provider Contact person
Comité de Ensayos Interlaboratorios del Instituto Nacional de Salud

51
Peru

Phone: 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
Phone: 975148486
Fax:
Email: falva@ins.gob.pe falva@ins.gob.pe
If you find any mistakes please contact the responsible EPTIS coordinator in Peru, Ms María Teresa Huayta. Ms María Teresa Huayta.
Any questions or problems? Please contact us at eptis@bam.de.
Application version: 1.21