Global Fund Quality Assurance Policy and Plan

Quality assurance (QA) refers to the policies and procedures required to ensure that health products that reach patients are safe, effective and acceptable to the patient. For pharmaceutical products, this process involves, among other things, registration, prequalification and quality control.

  • QA is an essential part of the procurement and supply management (PSM) activities for Global Fund grants. The Quality Assurance Plan (QAP) is the key reference document for all QA and quality control (QC) activities for pharmaceuticals under the Global Fund grants. Together with the PA plan and/or the Pharmaceutical and Health Products Management (PHPM) country profile and the Global Fund's list of health products, it provides the key information on quality assurance for medicines.
  • QAP encompasses all activities that will ensure that the quality of pharmaceuticals is maintained along the supply chain until they reach the intended end users. It identifies objectives and key indicators for QA, specific QA activities, the budget related to all activities and the sources of funding.
  • The sharing of the QAP with the Global Fund is a good practice.
  • Each QAP will respond to the basic requirements of the Quality Assurance Policy of the Global Fund. From a risk-management perspective, the QAP is essential, since health commodities, bed nets and insecticides make up around 40 percent of the total grant value. Limiting risk for patients, health programmes, government, UNDP and the Global Fund in terms of the quality of these products is done by implementing the activities described in the QAP.
  • The key elements of the QAP are captured in the UNDP QAP template. Each of the specific activities are to be entered in this template. Parts that, after consultation with all partners, are considered non-essential for the specific country context, can be deleted; others that require more attention can be expanded and more detailed, with new elements introduced, if required.

Key elements of the QAP include:

  1. Introduction
  2. Supply sourcing
  3. Transport requirements
  4. Transit
  5. Receiving
  1. Quality control of pharmaceuticals
  2. Storage at peripheral level
  3. Distribution
  4. Storage at central level
  5. Pharmaceutical waste management
  1. Pharmacovigilance
  2. Rational drugs use
  3. Capacity development
  4. Roles and responsibilities for medicines' quality assurance
  5. Financing