Quality Assurance of Pharmaceuticals - A Compendium of Guidelines and Related Materials - Volume 1
(1997; 248 pages) [French] View the PDF document
Table of Contents
Close this folderIntroduction
View the documentNational drug regulation
View the documentProduct assessment and registration
View the documentGood manufacturing practices and inspection
View the documentDistribution
View the documentThe international pharmacopoeia and related activities
View the documentBasic tests
View the documentLaboratory services
View the documentInternational trade in pharmaceuticals
View the documentCounterfeit products
View the documentTraining
View the documentConclusion
Open this folder and view contents1. National drug regulation
Open this folder and view contents2. Product assessment and registration
Open this folder and view contents3. Distribution
Open this folder and view contents4. The international pharmacopoeia and related activities
Open this folder and view contents5. Basic tests
Open this folder and view contents6. Laboratory services
Open this folder and view contents7. International trade in pharmaceuticals
Open this folder and view contents8. Counterfeit products
Open this folder and view contents9. Training
View the documentSelected WHO publications of related interest
View the documentBack cover
 

Distribution

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.

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