- All > Medicine Access and Rational Use > Supply Management
- All > Quality and Safety: Medicines > Quality Assurance
- All > Prequalification of Medicines > WHO-UNICEF-UN Project
- Keywords > assessment - procurement agency
- Keywords > distribution and storage system
- Keywords > Good Storage Practices (GSP)
- Keywords > inspection
- Keywords > Model Quality Assurance System (MQAS)
- Keywords > packaging, repackaging, labelling, relabelling
- Keywords > prequalification of medicines
- Keywords > procurement agencies - quality assurance system
- Keywords > quality assurance - purchasing
- Keywords > supply agencies
(2014; 20 pages)
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 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. The assessment tool is based on the six modules in the MQAS:
- Module I General requirements for procurement agencies
- Module II Prequalification
- Module III Purchasing
- Module IV Receiving and storage
- Module V Distribution
- Module VI Reassessment
The tool covers the topics each of the above-listed Modules below. The logical flow considered is the quality system and infrastructure of the PA under assessment, how the PA performed prequalification, then purchasing of the products followed by the receiving and storage thereof. The last two modules then focus on the receiving of orders and dispatch of products followed by the reevaluation concept.
The tool should be used by qualified, experienced persons when assessing a PA (including wholesalers and distributors) for compliance with recommended international standards. It can also be useful for a PA when doing a self-assessment. The tool is not a checklist, but serves as a document to help and remind inspectors as to what should be assessed during inspections of PAs.