Quality Assurance Information

Quality assurance refers to the management activities required to ensure that the medicines (and/or other health products) that reach patients are safe, effective and acceptable to the patient. These activities may include, but are not limited to, (pharmaceutical products) registration, pre-qualification and quality control.

We strongly encourage you to visit this site frequently and make sure to use the most recent version when considering the procurement options.

Procurement Practices to Assure Quality

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”.

Compliance with National Regulations

Pharmaceuticals and other health products procured with Global Fund resources 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).

Pharmacovigilance

Pharmacovigilance (PV) is defined by the World Health Organization (WHO) as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems”. Pharmacovigilance is of paramount importance for Global Fund-financed programs to enhance program effectiveness and the safety and quality of medicines. It is critical for the assessment of risks and benefits of deploying new medicines for large scale use. The Global Fund, in close collaboration with WHO and Partners, is in the process of reviewing its approach towards Pharmacovigilance strengthening as described in the document ‘PV concept note Oct 2010 doc in progress’.