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


The quality of pharmaceuticals has been a concern of the World Health Organization (WHO) ever since its inception. The setting of global standards is requested in Article 2 of the WHO Constitution which cites as one of the Organization’s functions that it should “develop, establish and promote international standards with respect to food, biological, pharmaceutical and similar products”.

Every government allocates a substantial proportion of its total health budget to drugs. This proportion tends to be greatest in developing countries, where it may exceed 40%.

Without assurance that these drugs are relevant to priority health needs and that they meet acceptable standards of quality, safety and efficacy, any health service is evidently compromised. In developed countries considerable administrative and technical effort is directed to ensuring that patients receive effective drugs of good quality. It is crucial to the objective of health for all that a reliable system of drug control be brought within the reach of every country.

The supply of essential drugs of good quality was identified as one of the prerequisites for the delivery of health care at the International Conference on Primary Health Care in Alma-Ata in 1978. Similarly, the Conference of Experts on the Rational Use of Drugs, held in Nairobi in 1985, and WHO’s Revised Drug Strategy, adopted by the World Health Assembly in May 1986, identified the effective functioning of national drug regulation and control systems as the only means to assure safety and quality of medicines. Yet the World Health Assembly continues to express great concern about the quality, safety and efficacy of medicines, particularly those products or active pharmaceutical substances imported into, or produced in, developing countries. In recent years counterfeit products have infiltrated certain markets in disquieting proportions. Since the founding of WHO, the World Health Assembly has adopted many resolutions requesting the Organization to develop international standards, recommendations and instruments to assure the quality of medicines, whether produced and traded nationally or internationally.

In response to these resolutions, the WHO Expert Committee on Specifications for Pharmaceutical Preparations, which was originally created to prepare The international pharmacopoeia, has made numerous recommendations relevant to quality assurance and control. Most of these recommendations, even if they were made several years ago, are still valid. Thus far, however, most have been available only as separate sets of recommendations contained in annexes to various WHO Technical Reports. The recommendations are essential to all concerned with the quality assurance of medicines, but separate publication over a period of years made it difficult to recognize them as complementary parts of a comprehensive system of quality assurance.

To provide easy access to this information, the appropriate annexes are being reproduced in the two volumes of this publication. They are supplemented with other material relevant to the quality assurance of pharmaceuticals, some already issued in the form of WHO documents. The information is not necessarily presented in chronological order of original issue. Instead it is presented in logical sequence as a series of administrative instruments and technical elements of an overall quality assurance system. Readers should bear in mind that, in certain previously published texts, reference is made to WHO guidelines and other documents that have since been updated. Some of these updated texts are themselves included in the compendium and others are mentioned in this introductory section or listed inside the back cover of the book. All material relating specifically to good manufacturing practices (GMP) and inspection of pharmaceutical manufacturers will appear in Volume 2 of this publication. The actual standards for analytical controls are contained in The international pharmacopoeia. Other relevant publications include Basic tests for pharmaceutical substances and Basic tests for pharmaceutical dosage forms.

WHO has addressed not only pharmaceutical aspects of the quality of medicines, but also the intrinsic safety and efficacy of pharmacologically active substances. Advice on this has been published in the reports of the WHO Expert Committee on Essential Drugs, the WHO model prescribing information series, the WHO pharmaceutical newsletter, and the quarterly WHO drug information. From there relevant information is carried over into the regularly updated United Nations Consolidated list of products whose consumption and/or sale have been banned, withdrawn, severely restricted or not approved by governments.

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