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WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 834 - Thirty-third Report
(1993; 36 pages) View the PDF document
Table of Contents
View the documentWHO Expert Committee on Specifications for Pharmaceutical Preparations
View the document1. Introduction
Open this folder and view contents2. The international pharmacopoeia and related activities
Open this folder and view contents3. International Chemical Reference Substances and International Infrared Reference Spectra
View the document4. Quality control methods for medicinal plant materials
View the document5. The WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce
Open this folder and view contents6. Good manufacturing practices for pharmaceutical products
View the document7. Development of globally acceptable standards for excipients
Open this folder and view contents8. Stability of dosage forms
View the document9. Simple test methodology
View the document10. Quality assurance in pharmaceutical supply systems
Open this folder and view contents11. Pharmaceutical production in developing countries
View the document12. Training
View the documentAcknowledgements
View the documentReferences
View the documentAnnex 1 - List of available International Chemical Reference Substances1
View the documentAnnex 2 - List of available International Infrared Reference Spectra
Open this folder and view contentsAnnex 3 - Good manufacturing practices for biological products1
View the documentBack Cover
 

5. The WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce

With respect to the revised guidelines for implementing the expanded Certification Scheme published as Annex 3 of the report on the thirty-second meeting of the Committee (3), it was noted that, in May 1992, the World Health Assembly had adopted resolution WHA 45.29 in which it urged Member States inter alia to “issue certificates within five years in a form to be agreed in the light of experience gained in preliminary field testing”. The Committee requested that WHO and other international organizations should take every opportunity to promote the use of the Certification Scheme.

As foreshadowed in the previous report, work had been carried out on proposals for the certification of active ingredients. A significant difference between active ingredients and pharmaceutical products was that many Member States did not assess and register the former per se. In these circumstances, certification could only attest to the inclusion of the active ingredients in one or more finished dosage forms approved for marketing in the country concerned. The Committee agreed that, in finalizing the draft proposals in consultation with Member States, it should be stressed that certification of an active ingredient was an additional safeguard and not a substitute for analysis of the material by those responsible for the manufacture of the dosage forms.

 

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