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
Open this folder and view contents4. Handling and distribution of reference substances
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

2. Evaluation of reference substances

Evaluation of the suitability of a material proposed for use as a reference substance requires careful testing. It is necessary to consider all data obtained by examining the material, employing a wide variety of analytical methods. When taken as a whole they give confidence that the material is suitable for the intended use. Depending on the intended use of the substance, testing can be more or less searching and involve a number of independent laboratories.

In the case of reference substances that are intended for use in the identification tests or in the determination of purity, the examination may be carried out without a unified programme, all analytical data obtained in different laboratories being then considered. If compatible results are obtained in all the collaborating laboratories, a positive decision concerning the suitability of the material can be arrived at. The procedure may be simplified in the case of the evaluation of replacement batches of an existing reference substance.

When it is necessary to assign quantitative values to a reference substance, a collaborative study, following a carefully designed protocol and employing at least three cooperating laboratories, should be undertaken.

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