• Quality Assurance of Diagnostic Products

    Effective from 5 February 2014.

    NOTE: The QA Policy shall apply with immediate effect for all Diagnostic Products as defined in section 7 and 8, except the requirements defined in section 8 for HIV Virological and CD4 Technologies which shall commence and apply in full force and effect on 1st July 2014.

    1. Quality Assurance Policy for Diagnostic Products
    2. Applicable laws and regulations
    3. Clinical Standards and Selection of product types
    4. Quality standards for manufacturing sites
    5. Quality standards for products
    6. Ensuring quality of use
    7. Additional provisions
    8. Contact us 

    Quality Assurance Policy for Diagnostic Products

    The QA Policy applies to all durable and non-durable in vitro diagnostics (IVDs) , and imaging equipment and microscopes,  used in Global Fund financed programs for diagnosis, screening, surveillance or monitoring purposes.


    QA Policy requirements to be observed when procuring diagnostic products with grant funds


    Applicable Laws and Regulations: Observe all applicable laws and regulations


    Clinical standards and Selection of product types: Select appropriate product types (e.g. types of rapid tests, types of diagnostic equipment)  in compliance with WHO guidance or national guidelines


    Quality standards of manufacturing site: Ensure that the manufacturing site is compliant with the requirements of ISO 13485 OR ISO 9000 series as applicable applicable or an equivalent Quality Management System recognised  by one of the Regulatory Authorities of the Founding Members of the Global Harmonization Task Force (GHTF), i.e. USA, Japan, EU, Canada, Australia

    • See QA Policy, Section 7
    • Examples of diagnostic product types and applicable requirements
      download [ PDF - 145 KBEnglish ]

    Quality standards of products: Ensure that HIV Immunoassays, HIV Virological and  CD4 technologies, tuberculosis Diagnostic Products and Malaria Rapid Diagnostic Tests  comply with the following requirement

    Recommended by WHO after technical review of product quality and performance:

    OR

    Authorized for use by a regulatory authority of a founding member of the Global Harmonization Task Force (GHTF), i.e. USA, Japan, EU, Canada, Australia for HIV immunoassays and HIV Virologocal Technologies

    OR

    Acceptable for Procurement using Grant Funds, based on the advice of an Expert Review Panel 


    Ensuring quality of use: Lot testing - Undertake lot testing of malaria RDTs considering availability of WHO guidance and capacity

    • For malaria, see list of accredited laboratories and procedure for sending samples in WHO RDT Lot Testing Programme in WPRO 

    Guidance for best practice:

    • Comply with WHO guidance on storage and distribution,
    • ensure use by appropriately trained and suitably qualified persons only
    • use best efforts to participate in suitable External Quality Assessment (EQA) programmes,
    • use best efforts to organize calibration and maintenance of relevant equipment,
    • use best efforts to develop systematic reporting of product defects
    • See QA Policy, Sections 10-14
    • List of relevant guidance [ PDF - 174 KBEnglish ]
    • Programming of laboratory investments with a focus on viral load testing
      download [ PDF - 927 KBEnglish ]

    Budgeting: Include the cost of quality assurance and quality monitoring measures in grant budgets


    Additional provisions: Ensure disclosure of the manufacturer and manufacturing site in all tender and procurement documentation. Observe all Global Fund policies and principles as applicable to Diagnostic Products

    Transitional provisions: Notify the Global Fund of any existing contracts or tenders in progress which do not comply with this policy. After 1 March 2011 such contracts may not be extended or renewed


    For any queries you may have, please feel free to contact us