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.
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.
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
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:
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
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
Guidance for best practice:
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
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