WHO Technical Report Series, No. 981 - World Health Organization

8. Quality assurance – distribution and
trade of pharmaceuticals
8.1 Revision of model quality assurance
system for procurement agencies
The model quality assurance system (MQAS) for procurement agencies was
adopted by the Expert Committee in October 2005, since when it has been
used by many organizations. At a GFATM–WHO joint stakeholders meeting in
August 2011, WHO and GFATM identified the need for revision of the MQAS
and the need for an assessment tool for procurement agencies. The MQAS
was reviewed and a proposal for revision initiated; and an assessment tool was
developed with major procurement organizations and agencies. Both activities
followed a consultative process. During this process, it was noted that not all the
procurement organizations used the system.
Two informal meetings were organized by GFATM in 2012 to review
progress in both the MQAS and the proposed new assessment tool. The revised
MQAS and the proposed assessment tool were then circulated for comment
in August 2012 by WHO following the usual Expert Committee consultation
process. Comments were collated and the draft revised MQAS and the comments
were presented to the Expert Committee for consideration.
The Expert Committee considered the comments and proposed a number
of amendments to the draft. The Expert Committee endorsed the proposal for a
revision of the MQAS, and noted progress made to date.
8.2 Assessment tool based on the model
quality assurance system
In August 2011, WHO and GFATM identified the need for a new assessment tool
for procurement agencies in conjunction with the revision of the MQAS. The
proposed assessment tool was based on the MQAS. A draft of the proposed tool
was prepared during 2012 and was circulated for comment. The draft was being
tested in a pilot process from August to December 2012, after which it would be
further reviewed and revised according to the experience gained.
The Expert Committee endorsed the proposal to develop a new assessment
tool based on the MQAS, thanked the GFATM for financing the initiative, and
noted progress made to date. It was requested that the assessment tool should be
published as an appendix to the MQAS.
8.3 Monitoring and surveillance of national supply chain
WHO has recently initiated a project focusing specifically on building global
capacity for surveillance and monitoring of SSFFC medicines; the project
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