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
Fermer ce répertoire1. INTRODUCTION
Afficher le document1.1 Background
Afficher le document1.2 WHO Certification Scheme
Afficher le document1.3 Types of Certificates
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
 

1.1 Background

International trade in pharmaceutical products encompasses many thousands of products. The value of the global pharmaceutical market is estimated to exceed US$ 200 billion per year. Some 20-30% of this amount involves international trade, while the remaining amount consists of drugs that are produced and consumed within individual countries. The dependence on imported pharmaceutical products differs between countries. In developing countries, particularly the least developed, the dependence on the importation of pharmaceutical products is much greater. In many cases it may reach 100%, as with Central African Republic, Fiji, Malawi, and Papua New Guinea, included in the present study.

The movement of pharmaceutical products in international commerce necessitates various safeguards on the part of importing countries and institutions to assure that pharmaceutical products are safe, effective, and of adequate quality when received.

The approach to quality assurance of pharmaceutical products includes a number of elements: a decision that the product is effective and safe; assurance of appropriate manufacturing conditions for its production and confirmation that these conditions fulfil requirements for Good Manufacturing Practices (GMP); and assurance of the quality of every batch through appropriate analytical testing. In the case of imported products, additional analytical testing is done to confirm that the batch received did not deteriorate in transit.

Looking at the administrative side, quality assurance of an imported product would ideally include the following elements:

a) registration of the product in the country of manufacture;

b) approval of manufacturing conditions by pharmaceutical inspection of the manufacturing plant;

c) quality analysis of a batch of the product by the manufacturer's laboratory before the product is released;

d) licensing of the product in the country of importation;

e) quality analysis of a sample of the product taken from every batch after receipt of goods at the country of destination.

Such an ideal situation is only rarely met in practice as it would require the existence and proper operation of regulatory authorities in both the exporting and importing countries and a considerable expenditure of resources. In most developing countries, the necessary resources are non-existent. The approaches used in practice by the majority of importing countries are, therefore, aimed at obtaining at least a partial assurance that imported products are licensed and approved for use in the country of origin, and are of acceptable quality.

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