The Twenty-eighth World Health Assembly, in resolution WHA28.66, enumerated a number of objectives relating to regulatory control of drugs. In consequence, in its twenty-seventh report, the WHO Expert Committee on Specifications for Pharmaceutical Preparations discussed the various elements of quality assurance in pharmaceutical supply systems (see Chapter 3).

Although parts of the elements described in Chapter 3 have been incorporated into or expanded in the guidelines for small national drug regulatory authorities, the text still provides a succinct review of quality assessment and assurance, premarketing quality assessment, and drug surveillance during marketing.

Pharmacists play an important role in the distribution of pharmaceuticals and must ensure that the service provided to patients is of appropriate quality. Guidelines on good pharmacy practice have been prepared by the International Pharmaceutical Federation in collaboration with WHO to encourage national pharmaceutical organizations to focus the attention of pharmacists in the community and hospital pharmacy sector on developing the elements of their services to meet changing circumstances. They provide a framework within which each country can set standards relevant to its own aspirations and needs.

The guidelines were presented in April 1997 to the WHO Expert Committee on Specifications for Pharmaceutical Preparations and will be included as an annex to the Committee’s report. Copies of the text can be obtained from the Regulatory Support unit, Division of Drug Management and Policies, WHO, 1211 Geneva 27, Switzerland.