WHO TRS (Technical Report Series) 986, 2014 Annex 4

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WHO TRS (Technical Report Series) 986, 2014 Annex 4

Assessment tool based on the model quality assurance system for procurement agencies: aide-memoire for inspection

1. Introduction:

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.

The Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM) Secretariat coordinated this project with the aim of preparing a harmonized assessment tool based on the WHO documents: Model quality assurance system for procurement agencies (MQAS); WHO guidelines on good storage practices (GSP) and WHO guidelines on good distribution practices (GDP) (for current versions, see www.who.int/medicines).

This harmonized tool was developed by a working group consisting of representatives from the following organizations: Committee for Medicinal Products for Human Use (CHMP), Crown Agents, global drug facility (GDF), Global Fund to Fight AIDS, Tuberculosis and Malaria, 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), United Nations Children’s Fund (UNICEF), United Nations Office for Project Services (UNOPS) and United States Agency for International Development (USAID).

2. Purpose:

This harmonized tool was developed by the working group with the objective that it could result in better use of resources by coordinating procurement agency (PA) assessments; and working towards mutual recognition of the findings of PA assessments.

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WHO TRS (Technical Report Series) 986, 2014 Annex 4:
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