The Global Fund to Fight AIDS, Tuberculosis and Malaria

Quality Assurance of Diagnostic Products

Effective from 1 March 2011

Quality Assurance Policy for Diagnostic Products
National regulations
Selection of product types
Quality standards for manufacturing sites
Quality standards for products
Ensuring quality of use
Additional provisions
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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.	22nd Global Fund Board Decision Point, December 2010: Quality Assurance Policy for Diagnostic Products download [ PDF - 74 KB ] QA Policy for Diagnostic Products (“QA policy”) as issued on 14 December 2010) download [ PDF - 118 KBعربي中文EspañolFrançaisРусский ]
QA Policy requirement to be observed when procuring diagnostic products with grant funds
National regulations: Observe all applicable laws and regulations	See QA Policy, Section 5
Selection of product types: Select appropriate product types (e.g. types of rapid tests, types of diagnostic equipment) in compliance with national guidelines or WHO guidance	See QA Policy, Section 7
Quality standards of manufacturing site: Ensure that the manufacturing site is compliant with the requirements of ISO 13485 OR ISO 9000 series as applicable	See QA Policy, Section 8 Examples of diagnostic product types and applicable requirements download [ PDF - 145 KB ]
Quality standards of products: Ensure that HIV and Malaria immunoassays comply with the following requirement	See QA Policy, Sections 9-10 and Section 17
Recommended by WHO after technical review of product quality and performance OR	List of Malaria RDTs based on WHO evaluations and WHO Information note on Recommended Selection Criteria for the Procurement of Malaria RDTs WHO List of HIV Products in 2012 indicating HIV diagnostic products eligible for procurement according to WHO evaluation as detailed in WHO website. Please note that a PR can use Global Fund financing to purchase product(s) not listed in the current list as long as PR demonstrates that the product is compliant with the Global Fund Quality Assurance Policy (.i.e. authorized for use by a regulatory authority member of GHTF)
Authorized for use by a regulatory authority which is a member of GHTF (USA, Japan, EU, Canada, Australia	GHTF (website for general information). More detailed information will follow shortly
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 [Contacts: mal-rdt@wpro/who.int ]
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 11-14 List of relevant guidance [ PDF - 174 KB ]
Budgeting: Include the cost of quality assurance and quality monitoring measures in grant budgets	See QA Policy, Sections 11-14
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	See QA Policy, Sections 16-17 PSM guide and plan template
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	QA Policy, Section 18

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