Drug Assay Directory
The Drug Assay Directory is a searchable database, downloadable as an excel spreadsheet, developed by the CPQA Program. The Drug Assay Directory allows users to easily identify the CPQA approved assay methods at DAIDS-funded CPLs. The database includes each assay’s details for acceptable specimen collection, processing and storage, as well as other pertinent information.
This document explains how to use the Drug Assay Directory.
Procedures and Guidance
This document provides an overview of the proficiency testing program, the responsibilities of testing laboratories, and an explanation of the proficiency testing process.
This document is a guideline that describes the CPQA assessment practices and procedures. The purpose of the CPQA assessment is to identify appropriate quality recommendations for the development, implementation or operations of the laboratory assessed. This document is for informational purposes and provides guidance for the potential laboratory assessment candidates such as laboratory resources, facilities, operations, qualifications and documentation.
This guidance document represents recommendations from CPQA for validating bioanalytical methods for use in analyzing NIAID/DAIDS study specimens. These recommendations were adopted from the May 2001 US Food and Drug Administration (FDA)’s Guidance for Industry: Bioanalytical Method Validation, regulatory agency/industry, consensus opinions from the December 2013 Crystal City V Meeting, and best practices published in industry white papers. It is strongly recommended that, at a minimum, CPQA participating CPLs follow these CPQA guidelines as described in this document for validating and performing analyses for NIAID/DAIDS sample applications.