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


Recommendations and guidelines provide an essential foundation for the development and maintenance of quality assurance of pharmaceutical products. But it is personnel who are crucial to quality assurance at all levels of pharmaceutical manufacture, regulation and distribution.

Pharmacists have an important contribution to make in public health and particularly in the field of medicines. WHO meetings on the role of the pharmacist in the health care system were held in New Delhi in 1988 and in Tokyo in 1993, and the World Health Assembly, in resolution WHA47.12, has stressed the key role pharmacists can play in the rational use and quality assurance of medicines.

By virtue of their training, pharmacists can play a part in drug regulation and control, particularly in the evaluation of pharmaceutical formulations at the time of product registration, and in the licensing and inspection of pharmaceutical manufacturing plants and distribution channels. In addition to their work in central medical stores, hospitals, pharmacies and other drug outlets, trained pharmacists may also contribute to quality assurance by assisting in pharmaceutical manufacture, in drug procurement and in distribution.

While quality assurance is founded on regulations and standards, it is the people who enforce the regulations or work to comply with the standards who make the difference between quality assurance and lack of it. The assurance of quality, safety and efficacy of medicines is a continuing concern of WHO. This compilation of material is intended to assist all involved in the manufacture, regulation and distribution of pharmaceuticals to achieve these aims more effectively


to previous section
to next section
The WHO Essential Medicines and Health Products Information Portal was designed and is maintained by Human Info NGO. Last updated: December 6, 2017