COVID-19 Response: Quality Assurance
COVID-19 impacts health product supply globally, and the Global Fund is working to minimize disruption to health systems in the countries we support.
We are exercising flexibilities to ensure the continued flow of quality-assured health products and support countries in their response to the pandemic. Our operational guidance lays out new quality assurance requirements for procuring COVID-19 diagnostic products with Global Fund financing.
Read more on our COVID-19 Quality Assurance page.
Quality assurance is ensuring health products – everything from medication to microscopes – purchased and used by Global Fund-supported programs are safe, effective, of good quality and available to the patient.
Quality assurance at the Global Fund includes a framework of processes, standards and requirements that apply to products as well as practices.
For supply chain management, this means ensuring that:
- The source and quality of the raw materials entering into the finished product meet accepted quality standards
- Manufacturing processes are in line with international quality standards
- Quality control measures are in place and adequate
- Appropriate regulatory approvals and marketing authorizations are in place
- Procurement and logistics systems maintain the quality of the products and support access and availability
- Information is provided in timely fashion to patients and health care professionals
- The management of end-of-life of health care products considers environmental concerns
Key stakeholders in quality assurance include:
- Manufacturers
- National regulatory authorities
- Quality control laboratories and pharmacovigilance centers
- National procurement systems
- International agencies
- Health care providers
Requirements
The Global Fund maintains quality assurance policies for pharmaceutical products, for diagnostic products and for other health products:
- Quality Assurance Policy for Pharmaceutical Products
download in عربي | 中文 | English | Español | Français | Русский - Quality Assurance Policy for Diagnostic Products
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In addition to following these policies, Principal Recipients must ensure that all pharmaceutical products are procured in accordance with the principles set out in the Model Quality Assurance System for Procurement Agencies interagency guidelines, available below for download.
Pharmaceuticals and other health products procured with Global Fund funds must comply with national regulations and, where applicable, be authorized by the national drug regulatory authority in the country in which they are used, following its standard practices for registration (or other forms of authorization, such as authorizations for special use).
In using pharmaceuticals, Principal Recipients are also expected to maintain pharmacovigilance – the detection, assessment and prevention of adverse effects of medicines or any other possible drug-related problems. Pharmacovigilance is a critical concern, as it affects the assessment of the risks and benefits possible in deploying new medicines for large-scale use. Pharmacovigilance enhances program effectiveness as well as the safety and quality of medicines.