WHO TRS (Technical Report Series) 986, 2014 Annex 3

Sathyanarayana M.Sc.
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WHO TRS (Technical Report Series) 986, 2014 Annex 3

Model quality assurance system for procurement agencies

Background:

The Expert Committee on Specifications for Pharmaceutical Preparations of the World Health Organization (WHO) adopted a Model quality assurance system for procurement agencies (MQAS) during a meeting in Geneva, Switzerland in 2005. This was subsequently published as Annex 6 in the Technical Report Series, No. 937 in 2006. Some procurement organizations have implemented the recommendations presented in the MQAS. Some donor organizations (including the Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM)) have endorsed the MQAS as part of their quality assurance policy for the procurement of pharmaceutical products with their funds. Several organizations have also prepared a tool to assess procurement agencies to establish the level of implementation and compliance with the MQAS.

Participants at a WHO/GFATM joint stakeholders meeting on Quality Assurance for Essential Medicines held in August 2011 in Geneva agreed that a working group consisting of representatives from the Committee for Medicinal Products for Human Use (CHMP), Crown Agents, Global Drug Facility (GDF), International Committee of the Red Cross (ICRC), International Development Association (IDA), Médecins Sans Frontières (MSF), Management Sciences for Health (MSH), Partnership for Supply Chain Management (PFSCM), Quality Medicines for All (QUAMED), International Union Against Tuberculosis and Lung Disease (The Union), United Nations Children’s Fund (UNICEF), United Nations Office for Project Services (UNOPS), and the United States Agency  for International Development (USAID), be created to develop a harmonized Assessment Tool that could be used by all with the aim of better use of resources by coordinating procurement agency assessments and working towards mutual recognition of procurement agency assessment findings, and to participate in the revision of the MQAS.

The Global Fund Secretariat contracted a consultant through a competitive process in 2012 to review the existing MQAS and to make recommendations to WHO (in case the need was identified to change or update the MQAS), to review tools used by procurement agencies in the light of the existing MQAS and to prepare a harmonized tool for the assessment of procurement agencies, based on the MQAS, through a consultative process. 

Four informal meetings were also held at the Global Fund between 2012 and 2013 to discuss the MQAS, the comments, the draft tool, progress made and the way forward.

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WHO TRS (Technical Report Series) 986, 2014 Annex 3:
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