(1996; 200 pages)
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.