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

Summary and recommendations
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In response to the concern expressed by the Expert Committee at
the possible lack of candidate material for reference substances it was
suggested that manufacturers and national pharmacopoeias may be
able to assist. The Expert Committee requested the secretariat to react
to the new situation by approaching national pharmacopoeias to
assess what assistance could be provided.
External Quality Assurance Assessment Scheme (EQAAS)
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Continue the External Quality Assurance Assessment Scheme
(EQAAS) for pharmaceutical quality control laboratories, Phase 5,
onwards.
Continuation of the scheme with Phase 6, as funds allow.
Quality control laboratories
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Continue the survey on quality control laboratories performing
analysis of suspect spurious/falsely-labelled/falsified/counterfeit
(SFFC) medicines and report back on the outcome.
Good manufacturing practices (GMP) and manufacture
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Continue to follow up on the revision process for GMP for biologicals
undertaken under the aegis of the Expert Committee on Biological
Standardization.
Study the need for an update of the GMP general principles to cover
new developments globally.
Continue the review of the revised GMP training modules with a
view to making them publicly available as soon as possible.
WHO model quality assurance system for procurement agencies
In close collaboration with the Global Fund:
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Continue the process of revision of the model quality assurance
system for procurement agencies.
Continue the development of an assessment tool for procurement
agencies.
Update of good trade and distribution practices (GTDP)
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Continue the process of revision of GTDP in collaboration with
partner organizations specialized in this field.
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