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WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 863 - Thirty-fourth Report
(1996; 200 pages) View the PDF document
Table of Contents
View the document1. Introduction
Open this folder and view contents2. The international pharmacopoeia and related activities
View the document3. Simple test methodology
Open this folder and view contents4. Stability of dosage forms
Open this folder and view contents5. Good manufacturing practices for pharmaceutical products
Open this folder and view contents6. Legal and administrative aspects of the functioning of national drug regulatory authorities
Open this folder and view contents7. Quality assurance in the supply system
View the document8. Terminology
View the documentAcknowledgements
View the documentReferences
Open this folder and view contentsAnnex 1 - Guidelines for the graphic representation of chemical formulae
View the documentAnnex 2 - List of available International Chemical Reference Substances1
View the documentAnnex 3 - List of available International Infrared Reference Spectra
Open this folder and view contentsAnnex 4 - General recommendations for the preparation and use of infrared spectra in pharmaceutical analysis
Open this folder and view contentsAnnex 5 - Guidelines for stability testing of pharmaceutical products containing well established drug substances in conventional dosage forms
Open this folder and view contentsAnnex 6 - Good manufacturing practices: guidelines on the validation of manufacturing processes
Open this folder and view contentsAnnex 7 - Good manufacturing practices: supplementary guidelines for the manufacture of investigational pharmaceutical products for clinical trials in humans
Open this folder and view contentsAnnex 8 - Good manufacturing practices: supplementary guidelines for the manufacture of herbal medicinal products1
Open this folder and view contentsAnnex 9 - Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability
Open this folder and view contentsAnnex 10 - Guidelines for implementation of the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce
Open this folder and view contentsAnnex 11 - Guidelines for the assessment of herbal medicines1,2
Open this folder and view contentsAnnex 12 - Guidelines on import procedures for pharmaceutical products
View the documentBack Cover

3. Simple test methodology

The Committee noted the progress made in the development of tests additional to those already published by WHO in Basic tests for pharmaceutical substances and Basic tests for pharmaceutical dosage forms (6, 7). It recommended that these publications should be made available in all of WHO's official languages since that would significantly increase their usefulness. The Committee emphasized that these tests had been designed specifically for use where reagents and equipment needed to be kept to a minimum. Reagents that were unstable, corrosive, expensive or difficult to obtain were therefore excluded. The Committee approved the publication of those tests that had been finalized and offered some suggestions on how to accelerate the verification process. It recommended that, to avoid delays in making information on tests available, more frequent issuing of collections of tests should be considered. It 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. The discussion paper on analytical considerations in pharmaceutical regulation (8) would serve as a valuable introduction to such a supplementary section. The Committee was conscious of the need to take into consideration the different priorities and stages of development of national drug control laboratories and assist them in making the best use of available resources.

The provision of advice and information on simple test methodologies complemented the Committee's work on pharmacopoeial specifications. While the latter were an essential part of the independent assessment of overall product quality, simpler tests were a valuable tool for primary screening, which could play an important part in detecting counterfeit and spurious products. As an example of appropriate, simplified analytical technology, the Committee endorsed the usefulness of the thin-layer chromatography (TLC) kits, reference tablets and associated materials (9) that had been evaluated in a number of WHO Member States.


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