The Global Fund’s quality assurance policy for diagnostic products applies to all durable and non-durable in-vitro diagnostics, imaging equipment and microscopes used in Global Fund-supported programs for diagnosis, screening, surveillance or monitoring purposes.
Best practices in the procurement of diagnostic products include:
The cost of quality assurance and quality monitoring measures must be included in grant budgets. Those responsible for the procurement of diagnostic processes (in most cases, this will be the Principal Recipient of the grant) should ensure that they observe all applicable laws and regulations. In addition, World Health Organization guidelines or national guidelines should serve as the basis for the selection of particular products.
In situations where products are selected that have not been either prequalified by the World Health Organization Prequalification Programme or been authorized for use by a stringent regulatory authority, manufacturers can submit their product for review by the Expert Review Panel of the Global Fund.
The World Health Organization manages a program that prequalifies pharmaceutical and diagnostic products that are considered to be acceptable for procurement by the United Nations and specialized agencies. The organization regularly publishes the list of prequalified products.
A stringent regulatory authority is a regulatory authority that was founding member of the Global Harmonization Task Force, including the regulatory authorities of the United States, the European Union, Japan, Canada and Australia. In 2012, the task force was replaced by the International Medical Device Regulators Forum, a voluntary group of medical device regulators from around the world that build on the foundational work of the preceding harmonization task force.
If only one or no product is available on the global market, countries may select a product that has been reviewed by the Expert Review Panel and that is permitted for time-limited use.
In cases where Principal Recipients wish to purchase products that have been reviewed by the Expert Review Panel, they should obtain evidence of product status through the “no-objection letter” process. They should complete the notification form and submit it to their Fund Portfolio Manager. The Global Fund will issue a no-objection letter for a time-limited period and the procurement can go ahead.
In cases where the Principal Recipient has ordered a product that has been reviewed by the Expert Panel Review and has notified the Fund Portfolio Manager, the Global Fund will conduct quality control testing. This testing is carried out by an independent laboratory contracted by the Global Fund. Once the product has been successfully tested, the Global Fund will approve shipment, notifying both the Principal Recipient and the manufacturer.
In addition, the diagnostic equipment selected should be from manufacturers whose manufacturing sites are compliant with the requirements of ISO 13485 OR ISO 9000 series, as applicable (or an equivalent quality management system recognized by one of the regulatory authorities of the founding members of the Global Harmonization Task Force). All tender and procurement documentation should include a disclosure of the manufacturer and the manufacturing site used.
Compliant products are listed in the Related Resources section:
Note that the list is not exhaustive and a Principal Recipient can use Global Fund grant funds to purchase product(s) not listed in the current list, as long as the Principal Recipient can demonstrate that the product is compliant with the policies mentioned above.
Any grants procuring rapid diagnostic tests for malaria are responsible for undertaking lot testing of the kits once they have been received, taking into account the availability of World Health Organization guidance and capacity. See the list of accredited laboratories and procedure for sending samples in WHO Rapid Diagnostic Test Lot Testing Programme in the Western Pacific Regional Organization.