by Mike Bennoson

The World Health Organization (WHO) is the specialized United Nations agency for health. Established on 7 April 1948, the WHO has 192 member states, two governing bodies (the World Health Assembly and Executive Board) and a WHO Secretariat consistent of WHO Headquarters in Geneva, six regional offices and WHO expert panels.

The WHO's vision is a world in which:

• People everywhere have access to essential medicines they need;
• medicines are safe and effective; and
• medicines are prescribed and used rationally.

The WHO has a wide range of responsibilities including the issue of global quality assurance guidelines for medicines. These cover aspects from manufacture to delivery to the patient including:

• Production
• Quality
• Quality related regulatory guidelines
• Inspection
• Distribution

Just three years ago, ISPE offered the WHO assistance on the drafting of two global guidelines:

• Guideline for sampling of pharmaceutical and related materials (revision of existing guideline)
• GMP: water for pharmaceutical use (new)

The documents were drafted by ISPE teams with regular review by the WHO Expert Committee, following the usual WHO consultative process with members of the WHO Advisory Expert Panel in the area of drug quality assurance and numerous WHO partners. They have now been adopted by the 39th Expert Committee on Specifications for Pharmaceutical Preparations. Both documents are now posted on the WHO Web site and hard copies will be available soon.

A number of other WHO draft documents are currently in progress. ISPE provides comments on those which are relevant to the scope and expertise of the Society. Such documents include:

• Supplementary guidelines on GMP for heating, ventilation, and air-conditioning systems (HVAC)
• Supplementary guidelines on GMP: Validation
• Good Distribution Practices (GDP) for pharmaceutical products

For further information on the activities of the WHO, visit www.who.int or http://www.who.int/medicines/areas/quality_safety/quality_assurance/en/index.html.

About the Author
Michael J. Bennoson joined ISPE in May 1996 and supports the European office in the development of European educational programs and ISPE links with regulatory authorities. Bennoson obtained a Bachelor of Technology degree in industrial chemistry from the University of Bradford, England. He emigrated to Montreal, Canada where he spent four years in quality assurance at Ayerst Laboratories. He then emigrated to New Zealand and established GMP inspections for the government as head of inspection for the Department of Health. Upon his return to the UK, he joined Wellcome (now GSK) in quality assurance, retiring as director of quality assurance operations, UK in December 1995. Bennoson was chairperson of the UK industry GMP Committee for 13 years and participated in a number of European working groups.