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
 

Basic tests

Simplified or basic tests for pharmaceutical substances have been published in Basic tests for pharmaceutical substances in 1986 and Basic tests for pharmaceutical dosage forms in 1991. In 1994, the WHO Expert Committee on Specifications for Pharmaceutical Preparations suggested that the scope of the next publication on basic tests should be extended to include additional information on, and references to, other simple test methodologies. These are considered a valuable tool for primary screening and could play an important part in identifying counterfeit and spurious products. The third volume in the series of basic tests, which is in preparation for publication, will therefore refer to collections of simple tests other than those published by WHO. It will also contain details of basic tests for 23 additional pharmaceutical substances, 4 medicinal plant materials and 58 dosage forms. The substances covered by basic tests are mainly those included in WHO’s Model List of Essential Drugs.

In its twenty-eighth report, the WHO Expert Committee on Specifications for Pharmaceutical Preparations stated: “Basic tests are not, in any circumstances, intended to replace the requirements of pharmacopoeial monographs. The latter give an assurance of quality whereas basic tests merely confirm the identity”.

Basic tests do not need to be carried out by fully qualified pharmacists or chemists, but they should be performed by persons who have some understanding of analytical chemistry, such as required in courses for pharmaceutical assistants.

It is thus acknowledged that basic tests have a clearly defined but limited role. They have gained importance as screening tests to identify falsely labelled, spurious and counterfeit drugs.

Basic tests are developed in close collaboration with experts from all over the world and are tried in various laboratories to ensure their global applicability. Guidance on collaboration within the basic test programme, including a protocol for the development and verification of basic tests, was given in the twenty-ninth report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations and is contained in Chapter 5.

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: November 5, 2014