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
 

1.2 WHO Certification Scheme

In response to the need of developing countries to receive an assurance about the status and quality of imported products, the World Health Assembly (WHA) adopted in 1969, in resolution WHA22.50, requirements for "Good Practices in the Manufacture and Quality Control of Drugs" (GMP) (annex 1), together with the first version of the Certification Scheme. The Scheme provided for: a) the exporting country to establish, after inspection, an up-to-date list of manufacturers complying with GMP which could be exchanged between governments; and b) the issuance of batch certificates by the responsible health authorities of the exporting country.

Consultations with governments showed that neither the maintenance of lists of manufacturers, nor the issuance of batch certificates by authorities were feasible in practice. A revised version of the Scheme entitled " WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce" was thus submitted to the WHA in 1975. The revision was adopted in resolution WHA28.65 (annex 2). The 1975 version of the Scheme is based on certification by the responsible health authorities of: a) the registration status of a particular product in the exporting country; and b) of the GMP compliance of the responsible manufacturer. The issuance of a certificate for individual batches is relegated to the manufacturer.

After over a decade of experience with the scheme, it was felt that the 1975 version of the Scheme required further changes. It was revised and expanded in 1988 by the WHA in resolution WHA41.18. A modified form of the Certificate of a Pharmaceutical Product was attached to the resolution, superseding the 1975 form of this Certificate. The amendments of 1988 brought within the realm of the Scheme drug substances and finished dosage forms intended for human use, as well as a veterinary product administered to food producing animals. They also required the competent authority in the exporting country to provide copies of all approved product information and labelling as determined by the product license issued by the regulatory authority in the country of manufacture (annex 3).

In 1992, the WHA, in its resolution WHA45.29, endorsed the "Guidelines for implementation of the WHO Certification Scheme". This also contained a modified form for a Certificate of a Pharmaceutical Product which superseded the 1975 Certificate of a Pharmaceutical Product. Forms for a Statement of Licensing Status of Pharmaceutical Product(s) and for a Batch Certificate of a Pharmaceutical Product were also attached to the Guidelines (annex 4). In this resolution the WHA established a period of five years to evaluate and revise the proposed forms for the various certificates mentioned.

As at December 1994, the WHO Certification Scheme has been accepted by health authorities in 138 countries, both exporting and importing pharmaceuticals, which indicates their willingness to share the responsibility for the quality of drugs moving in international commerce.

The Scheme offers to importing countries information about:

a) the status of the pharmaceutical product;
b) the status of the manufacturer of the pharmaceutical product;
c) the quality of individual batches of the exported pharmaceutical product;
d) product information as approved in the country of export.

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