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
 

6. Means of promoting effective exchange of information and ensuring cooperation between organizations establishing reference substances

During the past few years, there has been an increasing exchange of information between laboratories concerned with the evaluation of reference substances. Cooperation that began on a personal and ad hoc basis is now, in some cases, being put on a more formal footing. There is a need, however, for circulating timely notifications of the work to be undertaken. In every instance, this should be done well before making any approach to a pharmaceutical manufacturer for the supply of material. In this way, it would be possible for a manufacturer to set aside a portion of a particular batch, so that sufficient of the proposed reference material would be available for all expected needs. The advantages of this procedure would be: first, that the studies carried out might be shared by collaborating laboratories; secondly, that the same reference material would be used by each issuing authority; thirdly, that if supplies of that material at one laboratory were depleted, appropriate arrangements might be made to share the remaining material from the other laboratories. Finally, there would be considerable benefit to industry since requests for the supply of reference materials would be coordinated and would be reduced in frequency.

In such a cooperative effort, it might also be possible for the manufacturer to pack the reference substance into appropriate standardized containers so that any variation due to storage and transport would be minimized.

From time to time, each laboratory will need to replace a certain number of reference substances. It would be advantageous for each laboratory to review its needs well in advance so as to permit a concerted request to be made to a manufacturer, thus achieving the benefits mentioned above.

to previous section
to next section
 
 
The WHO Essential Medicines and Health Products Information Portal was designed and is maintained by Human Info NGO. Last updated: August 29, 2014