Quality Assurance of Pharmaceuticals - A Compendium of Guidelines and Related Materials - Volume 1
(1997; 248 pages) [French] View the PDF document
Table of Contents
Open this folder and view contentsIntroduction
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
Close this folder4. The international pharmacopoeia and related activities
View the documentGuidance for those preparing or commenting on monographs for preparations to be included in The international pharmacopoeia1
View the documentValidation of analytical procedures used in the examination of pharmaceutical materials1
Close this folderGeneral guidelines for the establishment, maintenance, and distribution of chemical reference substances1
View the document1. Criteria for determining the need for the establishment of chemical reference substances
View the document2. Evaluation of reference substances
Open this folder and view contents3. Chemical and physical methods used in evaluating reference substances
Close this folder4. Handling and distribution of reference substances
View the document4.1 Packing and storage
View the document4.2 Stability and periodic re-evaluation
View the document4.3 Information to be supplied with reference substances
View the document4.4 Expiry of reference substances
View the document4.5 Distribution problems
View the document5. Reference materials calibrated against International Chemical Reference Substances
View the document6. Means of promoting effective exchange of information and ensuring cooperation between organizations establishing reference substances
View the documentGeneral recommendations for the preparation and use of infrared spectra in pharmaceutical analysis1
View the documentList of available International Chemical Reference Substances1
View the documentList of available International Infrared Reference Spectra1
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
4.4 Expiry of reference substances

The question of whether expiry dates should be assigned to reference substances is of great importance both to the users and to the distributors of the substances. The arguments against expiry dating are that it might lead to the unnecessary discarding of satisfactory materials and that considerable experimental work would first have to be carried out to make the setting of meaningful expiry dates possible.

If it is considered necessary to specify an expiry date in a particular case, the date should be stated on the label. At present, most reference substances are replaced by new batches only when this has been shown to be necessary by re-evaluation. This procedure minimizes unnecessary waste of valuable materials, but in order to make it completely satisfactory it would be necessary to devise effective means of informing analysts in possession of reference substances about any replacement of batches.

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