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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
 

ANNEX 1: Resolution adopted by the Twenty-second World Health Assembly

WHA22.50 Quality Control of Drugs

The Twenty-second World Health Assembly,

Recalling resolution WHA21.37;

Having considered the report for the Director-General on the quality control of drugs;

Noting with satisfaction the formulation of the "Principles of Pharmaceutical Quality Control"1 and "Good Practices in the Manufacture and Quality Control of Drugs"2 as presented in the report of the Director-General;

1Wld Hlth Org. techn. Rep. Ser., 1969, 418, Annex 1.

2 See Off. Rec. Wld Hlth Org. 176, Annex 12, part 1.


Recognizing that general observance of such principles and practices is essential and, in particular, a prerequisite for a system of certification for drugs in international commerce; and

Considering that general acceptance of such a certification system would be an important first step toward ensuring the desired level of quality control of drugs in international commerce,

1. RECOMMENDS that Member States adopt and apply

(1) the requirements for "Good Practices in the Manufacture and Quality Control of Drugs" as formulated in the report of the Director-General,2

(2) the certification scheme on the quality of pharmaceutical products moving in international commerce as formulated in the report of the Director-General as amended,3

 

3 See Off. Rec. Wld Hlth Org. 176, Annex 12, part 2.

2. REQUESTS the Director-General to report to the Twenty-third World Health Assembly

(1) on those improvements in the requirements for good manufacturing practice and in the certification scheme which may appear to be necessary; and

(2) on further progress with regard to the certification scheme and the implementation thereof.

July 1969

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