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

General policy
The Expert Committee thanked the Global Fund for its report and
expressed appreciation for its strong commitment to ensuring the highest quality
standards during the procurement and supply process.
United Nations Children's Fund
The United Nations Children's Fund (UNICEF) is present in some 170 countries.
Its Supply Division, located in Copenhagen, Denmark, procures supplies,
including medicines, for UNICEF and partners. UNICEF country offices do not
carry out procurement of medicines themselves. Ninety per cent of UNICEF
supplies are for Africa and Asia.
UNICEF prequalification of medicines applies to both suppliers and
products. UNICEF carries out good manufacturing practices (GMP) inspections
itself mainly to check compliance with WHO GMP guidelines. Around 100 GMP
inspections were carried out in 2007–2012, and 19 companies failed the inspection.
Virtually all pharmaceutical products supplied by UNICEF are on the
WHO Model List of Essential Medicines. Vaccines, human immunodeficiency
virus (HIV), antimalarial and antituberculosis medicines must be prequalified by
WHO and listed on the WHO Prequalification web site.
The Expert Committee thanked UNICEF for its report and expressed
appreciation for its strong commitment to ensuring the highest quality standards
during the procurement and supply process.
2.2.2 Pharmacopoeial Discussion Group
The Expert Committee received a report on the Pharmacopoeial Discussion
Group (PDG), of which WHO is an observer. At present, 28 of the 35 general
chapters and 43 of the 62 excipient monographs of the current work programme
have been harmonized. Representatives of the three pharmacopoeias that make
up the PDG discussed ways to improve and speed up the harmonization process
and proposed a number of options. Test procedures concerning excipient
adulteration were also discussed. The Expert Committee took note of the report.
2.2.3 International Conference on Harmonisation
The International Conference on Harmonisation of Technical Requirements
for Registration of Pharmaceuticals for Human Use (ICH) is reviewing its work
and making plans for the future. The ICH Steering Committee has agreed
to set up a quality brainstorming group, working chiefly by teleconference, to
advise ICH parties. Current plans include revision of guidelines, such as those
on specifications, and it is expected to proactively review which new guidelines
may be needed in the future. ICH has plans to develop training on its guidelines,
both within the ICH regions and outside. The following topics are currently
being pursued in the area of quality: Q3D (residual metals); M7 (genotoxic
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