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Use of the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce - EDM Research Series No. 016
(1995; 156 pages) Voir le document au format PDF
Table des matières
Afficher le documentACKNOWLEDGMENTS
Afficher le documentPREFACE
Afficher le documentEXECUTIVE SUMMARY
Ouvrir ce répertoire et afficher son contenu1. INTRODUCTION
Afficher le document2. RATIONALE AND OBJECTIVE OF THE ASSESSMENT
Afficher le document3. ACTIVITIES UNDERTAKEN: Preparations and Method of Work
Ouvrir ce répertoire et afficher son contenu4. ANALYSIS OF RESULTS FROM IMPORTING COUNTRIES
Ouvrir ce répertoire et afficher son contenu5. ANALYSIS OF RESULTS FROM EXPORTING COUNTRIES
Afficher le document6. ANALYSIS OF RESULTS FROM INTERNATIONAL SUPPLY AGENCIES
Ouvrir ce répertoire et afficher son contenu7. SUMMARY ANALYSIS
Afficher le document8. CONCLUSIONS
Afficher le documentANNEX 1: Resolution adopted by the Twenty-second World Health Assembly
Afficher le documentANNEX 2 (a): Resolution Adopted by the Twenty-Eighth World Health Assembly
Afficher le documentANNEX 2 (b): Certificate of Pharmaceutical Product(S)1
Afficher le documentANNEX 3 (a): Resolution adopted by the Forty-first World Health Assembly
Afficher le documentANNEX 3 (b): Certificate of Pharmaceutical Product(s)1 (Proposed Layout)
Afficher le documentANNEX 4 (a): Proposed Guidelines on the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce
Afficher le documentANNEX 4 (b): Certificate of a Pharmaceutical Product
Afficher le documentANNEX 4 (c): Statement of Licensing Status of Pharmaceutical Product(s) Model Statement of Licensing Status of Pharmaceutical Product(s)
Afficher le documentANNEX 4 (d): Manufacturer’s/Official Batch Certificate of a Pharmaceutical Product
Afficher le documentANNEX 5: Protocol for the Assessment of the Use of the WHO Certification Scheme by Importing Country
Afficher le documentANNEX 6: List of Participants in the Study
Afficher le documentANNEX 7: Protocol for the Assessment of the Use of the WHO Certification Scheme by Exporting Country
Afficher le documentANNEX 8: Protocol for the Assessment of the Use of the WHO Certification Scheme in an International Supply Organization
Afficher le documentANNEX 9: Study Instrument for Assessment of the WHO Certification Scheme by Importing Country
Ouvrir ce répertoire et afficher son contenuANNEX 10: Summaries of Mission Reports on the Assessment of the Use of the WHO Certification Scheme
Afficher le documentBACK COVER
 

6. ANALYSIS OF RESULTS FROM INTERNATIONAL SUPPLY AGENCIES

Several nongovernmental and "not-for-profit" institutions have created drug supply organizations that function on a global scale to provide essential drugs at low cost.

Two such organizations covered by the survey are: the UNICEF Supply Division, located in Denmark, and the International Dispensary Association (IDA), located in the Netherlands. These organizations (intermediary suppliers) provide pharmaceuticals to public and charitable health institutions and programmes in developing countries.

The organizations procure drugs on the international market from original manufacturers as well as contract manufacturers and transfer these products to their central warehouses. From there, they distribute them to the receiving countries.

The survey showed that the value of pharmaceuticals supplied in 1992 by UNICEF amounted to US$ 123 million (US$ 61 million worth of essential drugs and US$ 62 million worth of vaccines) and the main clients were developing countries in Africa and Asia. The drugs were purchased mainly from Austria, Belgium, Canada, France, Germany, Italy, Japan, Switzerland, UK, and USA. Procurement was done by means of open and restricted tender and by using a group of permanent suppliers.

In the case of IDA, the total supply during the same year amounted to US$ 60 million for a total turnover of US$ 80 million. The Organization has 20 regular and 100 irregular suppliers and the major importers are countries in Africa (70%); Central America (10%); and the Middle East (8%). Procurement is mainly from manufacturers in China, Europe, India and South Korea. Procurement is done by means of tender and by using a group of suppliers. IDA also has a formulation plant called PHARMAMED in Malta, which covers, in value terms, 20% of the supplies. The products manufactured by PHARMAMED are not registered in the Netherlands.

As observed during the survey, quality assurance of products distributed by IDA and UNICEF consists of the following elements:

a) review of product certificates obtained from suppliers;

b) review of suppliers by requesting GMP certificates, or a copy of the manufacturing license or a copy of the last inspection result;

c) audits by their own or international staff;

d) review of analytical batch certificates issued by the manufacturer;

e) visual inspection (appearance, labelling, containers) of received products;

f) laboratory testing of received products by random sampling.

Both agencies control the quality of purchased products by sampling all batches on arrival for visual review and by testing the quality of selected batches. In UNICEF’s case testing is done by collaborating laboratories. IDA makes basic tests in its own laboratory which is located in Amsterdam.

IDA and UNICEF also play the role of exporter. Therefore, they sometimes provide, on request, copies of analytical batch certificates issued by the original manufacturer of the batch. They also provide copies of original product certificates when requested by the importers.

The survey showed that the international supply agencies encounter difficulties in obtaining WHO-type certificates from exporting countries such as China, Germany, Italy, Spain and the UK. There are also doubts about the validity of certificates issued by some countries. This includes certificates issued by Chinese provincial health authorities and certificates issued in Germany for trading houses which do not have any production facility.

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