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CNASCL01-A026-2023 English PDF

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CNASCL01-A026-2023: Guidance on the Application of Testing and Calibration Laboratories Competence Accreditation Criteria in the Field of Drug Biological Samples
Status: Valid
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
CNAS CL01-A026-2023English559 Add to Cart 4 days [Need to translate] Guidance on the Application of Testing and Calibration Laboratories Competence Accreditation Criteria in the Field of Drug Biological Samples Valid CNAS CL01-A026-2023

Standard similar to CNASCL01-A026-2023

CNS 15388   CNAS EL02   CNAS CL01-S05   

Basic data

Standard ID CNAS CL01-A026-2023 (CNASCL01-A026-2023)
Description (Translated English) Guidance on the Application of Testing and Calibration Laboratories Competence Accreditation Criteria in the Field of Drug Biological Samples
Sector / Industry Chinese Industry Standard
Word Count Estimation 24,262
Date of Issue 2023-11-01
Date of Implementation 2023-11-01
Issuing agency(ies) China National Accreditation Service for Conformity Assessment
Summary This standard applies to CNAS's accreditation activities for laboratories in the field of drug biological sample analysis (hereinafter referred to as biological sample analysis) testing. Drug biological samples refer to whole blood, serum, plasma, urine and other samples obtained from animal non-clinical trials or human clinical trials in studies of drug pharmacokinetics, bioavailability/bioequivalence, etc. in organisms. This standard is only applicable to biological samples of drug clinical trials for testing objects.

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