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.

This page provides information, guidance and templates related to the Global Fund quality assurance policy for pharmaceutical products.

Multi-source pharmaceutical products

Multi-source pharmaceutical products are off-patent pharmaceutical products with publicly available quality assurance standards including, analytic methods and reference substances for the finished dosage form; that is, for which there is monograph for finished dosage form publicly available in the International Pharmacopoeia, the British Pharmacopoeia or the United States Pharmacopoeia.

In November 2007, at its Sixteenth Board Meeting, the Global Fund Board decided that any pharmaceutical products for the treatment of AIDS, tuberculosis and malaria for which the monograph of the finished dosage has been published in International, US or British Pharmacopeia after 10 October 2002, shall be subject to the QA Policy for Single and Limited-Source Pharmaceutical Products.

Single and Limited-source pharmaceutical products

"Single and limited sourced products are medical products for which there are no publicly available quality assurance standards, analytic methods, and reference substances"; that is, for which there are no publicly available monographs for the finished dosage form in the International Pharmacopoeia, the British Pharmacopoeia or the United States Pharmacopoeia.

The Global Fund Quality Assurance Policy related to procurement of:

• Multi-source pharmaceutical products
• Single and limited-source pharmaceutical products

• Original transcript of the Global Fund Board decision on Quality Assurance (April 2005)
  
  
• List of Countries that belong to ICH PICS
  
  
• Information Note of the Board Decision on Quality Assurance Policy
  (November 2007)
  
  
  
• List of Products Affected by the Board Decision
  (November 2007)
  
  
• Explanation Board Decision on QA Policy (November 2007)
  

FAQs related to policy on QA of single and limited-source pharmaceutical Products

Lists of ARVs, TB and Malaria products classified according to Global Fund Quality Assurance Policy

Process for procuring single and limited source pharmaceutical products compliant with C option

• Explanation of the application of the C Option
• Notification form
• Notification purchase order form

Frequently-Asked Questions (FAQs) about Quality-Control Testing of Pharmaceutical Products