Sources and Prices of Selected Products for the Prevention, Diagnosis and Treatment of Malaria
(2004; 70 pages) [French] Voir le document au format PDF
Table des matières
Afficher le documentGlossary
Ouvrir ce répertoire et afficher son contenu1. Introduction
Ouvrir ce répertoire et afficher son contenu2. How to use this report
Ouvrir ce répertoire et afficher son contenu3. Quality Assurance
Ouvrir ce répertoire et afficher son contenu4. Prices of products for the prevention, diagnosis and treatment of malaria
Ouvrir ce répertoire et afficher son contenu5. Index of Manufacturers
Ouvrir ce répertoire et afficher son contenuAnnex I Antimalarials
Ouvrir ce répertoire et afficher son contenuAnnex II Mosquito nets
Fermer ce répertoireAnnex III Diagnostics
Afficher le documentA. Summary of WHO recommendations
Afficher le documentB. The use of malaria rapid diagnostic tests
Afficher le documentC. Tendering and the availability of product information
Afficher le documentD. Integrating malaria RDTs into health services
Afficher le documentE. Maintaining a ‘cool chain’
Ouvrir ce répertoire et afficher son contenuAnnex IV Registration status of antimalarial medicines and insecticides included in the sources and prices survey
Afficher le documentAnnex V Further reading, websites and contacts
Afficher le documentAnnex VI Feedback and enquiry forms
 

C. Tendering and the availability of product information

Together with considerations of the sensitivity, species of parasite detected, and cost of a product, it is useful to know the quality of manufacturing processes and the stability of a manufacturer. The long-term viability of a company and consistency of production will influence the ability to replace a product should the received lot fail, and to ensure long-term supply of a product to minimize the need for re-training.

It is therefore recommended that purchasers request the following information from manufacturers during the tendering process:

1. Real-time temperature stability data on the product, and accelerated data on the purchased lot

2. Evidence of successful operational use, or good quality field data on the product

3. Evidence of long-term viability of manufacturer (to ensure continuity of supply)

4. Evidence of Good Manufacturing Practice /ISO certification(ISO13485:2003is specific for quality management systems for medical devices)

5. Availability of product support

6. Provision of sample products for assessment and testing for ease of use

7. Agreement for replacement of products which fail agreed quality control procedures (see above)

8. Box sizes appropriate to the rate of use of tests in the intended area, to minimize storage time in poor conditions and reduce the need to split boxes.


Points 3 and 4 imply that the place of manufacture of RDTs should be disclosed to the purchaser if RDTs are re-labelled.

Clarity of packaging of the end product is essential to allow identification of product type, production lots and expiry date.

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Dernière mise à jour: le 3 mai 2013