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

15. Summary and recommendations
The WHO Expert Committee on Specifications for Pharmaceutical Preparations
advises the Director-General of WHO in the area of quality assurance of
medicines. The Expert Committee provides recommendations and guidance for
the purpose of assuring the quality of medicines throughout their entire life-cycle,
i.e. from their initial development through to their final distribution to patients.
Since its creation in 1947, this Expert Committee has given independent
expert advice in the form of practical recommendations, clearly defined standards,
and international guidelines for quality medicines. The recommendations,
standards and guidelines adopted by the Committee are developed through a
broad international consensus-building process.
At its forty-seventh meeting from 9 to 12 October 2012, the Expert
Committee addressed a range of issues. These included the United Nations
Prequalification Programme which is managed by WHO, the prequalification
of quality control laboratories, WHO's External Quality Assurance Assessment
Scheme, a revision of the Organization's model quality assurance system, guidance
on making paediatric formulations available and a revision of WHO’s guidance
on good trade and distribution practices.
The Expert Committee reviewed specifications and tests for a number
of antiretroviral, antimalarial, anti-infective and other medicines, adopting
those that it judged to be suitable for inclusion as monographs in The
International Pharmacopoeia. General texts and supplementary information
sections of The International Pharmacopoeia were also reviewed and were
adopted where appropriate. In addition, arrangements for the quality control of
international reference materials were discussed and a number of ICRS and one
IIRS were adopted.
The work of this Committee in furthering access to high-quality
medicines relates to a number of other WHO committees and United Nations
bodies, as well as to national and regional authorities and procurement agencies
and to the pharmaceutical industry. Thus, the Committee's discussion included
issues that are being addressed by the WHO Expert Committee on Biological
Standardization, and the Expert Committee on the Selection and Use of Essential
Medicines and its subcommittee on Medicines for Children. Committee
members considered reports from the Global Fund to Fight AIDS, Tuberculosis
and Malaria and from the United Nations Children's Fund, as well as discussing
a variety of elements of regulatory guidance and a proposed revision to WHO's
advice on GMP. Training on GMP was discussed and advice was given on quality
risk management.
The Expert Committee noted considerable collaboration with other
bodies – particularly the FIP, with which WHO had jointly organized recent
conferences, and the International Conference of Drug Regulatory Authorities.
In addition, following WHO's convening of a meeting of pharmacopoeias in
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