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.
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22nd Global Fund Board Decision Point, December 2010: Quality Assurance Policy for Diagnostic Products
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QA Policy for Diagnostic Products (“QA policy”) as issued on 14 December 2010)
download (PDF - 118 KB)
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QA Policy requirement to be observed when procuring diagnostic products with grant funds
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| National regulations: Observe all applicable laws and regulations |
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| 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 |
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| 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)
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| Quality standards of products: Ensure that HIV and Malaria immunoassays comply with the following requirement |
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Recommended by WHO after technical review of product quality and performance
OR
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| 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
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| 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 ]
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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
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| Budgeting: Include the cost of quality assurance and quality monitoring measures in grant budgets |
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| 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 |
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| 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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