(1993; 36 pages)
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.