Sourcing & Management of Health Products

Quality Assurance

Quality assurance is ensuring that the health products that are purchased (everything from medication to microscopes) and used by Global Fund-supported programs are safe, effective, of good quality and available to the patient.

In the context of the Global Fund, this includes a framework of processes, standards and requirements that apply to products as well as practices. In terms of 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; and
  • The management of end-of-life of health care products considers environmental issues.

Key stakeholders in quality assurance include:

  • Manufacturers
  • National regulatory authorities
  • Quality control laboratories and pharmacovigilance centers
  • National procurement systems
  • International agencies
  • Health care providers

The Global Fund has published requirements for quality assurance specifically for pharmaceutical products, for diagnostic products and for other health products.

In addition to the Global Fund’s existing polices for procurement practices, Principal Recipients must ensure that all pharmaceutical products are procured in accordance with the principles set out in the interagency guidelines “A Model Quality Assurance System for Procurement Agencies” (English | Français).

Pharmaceuticals and other health products procured with Global Fund monies must at all times 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. This is defined as the detection, assessment and prevention of adverse effects of medicines or any other possible drug-related problems. Pharmacovigilance is a critical concern, as it impacts 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.