WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 885 - Thirty-fifth Report
(1999; 168 pages) [Spanish] View the PDF document
Table of Contents
View the documentWHO Expert Committee on Specifications for Pharmaceutical Preparations
View the document1. Introduction
Close this folder2. The international pharmacopoeia and related issues
View the document2.1 Quality specifications for drug substances and dosage forms
View the document2.2 Simple test methodology
Open this folder and view contents3. International Chemical Reference Substances and Infrared Reference Spectra
Open this folder and view contents4. Quality control - national laboratories
Open this folder and view contents5. Good manufacturing practices
Open this folder and view contents6. Quality systems and inspection
Open this folder and view contents7. Other quality assurance topics
Open this folder and view contents8. Nomenclature and terminology
Open this folder and view contents9. Legal aspects of pharmaceuticals
Open this folder and view contents10. Regulatory issues
Open this folder and view contents11. Training activities
View the document12. Pharmaceuticals contaminated with diethylene glycol
View the documentAcknowledgements
View the documentReferences
View the documentAnnex 1. List of available International Chemical Reference Substances1
View the documentAnnex 2. List of available International Infrared Reference Spectra1
Open this folder and view contentsAnnex 3. General guidelines for the establishment, maintenance and distribution of chemical reference substances
Open this folder and view contentsAnnex 4. Good manufacturing practices: authorized person - role, functions and training
Open this folder and view contentsAnnex 5. Good manufacturing practices: supplementary guidelines for the manufacture of pharmaceutical excipients
Open this folder and view contentsAnnex 6. Guidelines for inspection of drug distribution channels
View the documentAnnex 7. Good pharmacy practice in community and hospital pharmacy settings
Open this folder and view contentsAnnex 8. National drug regulatory legislation: guiding principles for small drug regulatory authorities
Open this folder and view contentsAnnex 9. Provisional guidelines for developing training programmes: inspection and examination of counterfeit pharmaceuticals
View the documentWorld Health Organization Technical Report Series
View the documentSelected WHO Publications of Related Interest
View the documentBack Cover
 

2.2 Simple test methodology

The Committee noted that a third volume to complement Basic tests for pharmaceutical substances and Basic tests for pharmaceutical dosage forms (3, 4) was in the process of publication. This volume would include references to other publications and documents, including some alternative tests based mainly on thin-layer chromatography and other simple methods. Work was continuing on the development of additional simple tests.

It was stressed that the basic tests should not be regarded as suitable or intended for use only in developing countries, but should be used more widely as quick testing methods as part of the preliminary screening of suspected counterfeit, spurious or substandard pharmaceutical products at various points such as ports of entry. It was suggested that some reference should be made in The international pharmacopoeia to the basic tests being complementary to, but not substitutes for, pharmacopoeial tests.

The Committee noted that Volumes 1-4 of The international pharmacopoeia (2, 5, 6, 7) and both publications of basic tests (3, 4) had already been published in English, French and Spanish. It recommended that the possibility of publishing them in other languages, including Russian, should be explored.

 

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