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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 8: Protocol for the Assessment of the Use of the WHO Certification Scheme in an International Supply Organization

1. GENERAL DATA ON THE ORGANIZATION

1.1 Name of organization; location of principal warehouses

1.2 General information on the activities

1.3 Economic Aspects

1.3.1 Total value of pharmaceuticals supplied in 1992.

1.3.2 Number of purchasing countries; list the main recipient countries giving the value of products purchased in 1992.

1.3.3 Payment modalities.

1.3.4 Level of prices and procedures used for their establishment.

 

2. FUNCTIONING OF PROCUREMENT AND QUALITY ASSURANCE MECHANISMS

2.1 Give main sources of supply

• number of manufacturers from which pharmaceuticals were purchased in 1992.

• main countries where these manufacturers were located.

2.2 In what way are contacts established with suppliers?

• by open tender.
• by a restricted tender.
• by using a group of permanent suppliers.

2.3 In what manner are quality specifications for procured pharmaceuticals formulated? (describe)

2.4 In what way is the quality of purchased products controlled?

 

• by analysing purchased products

Yes

No

• every batch

Yes

No

• selected batches only

Yes

No

• by reviewing batch certificates issued by the manufacturers

Yes

No

• for every batch

Yes

No

• for selected batches only

Yes

No

 


3. USE OF QUALITY CERTIFICATES INCLUDING WHO CERTIFICATION SCHEME MECHANISMS

3.1 Are WHO-type product certificates requested and received from suppliers?

 

• for every product

Yes

No

• for some products but regularly

Yes

No

• infrequently (explain)

3.3 INDICATOR 1

Give the number of product certificates received in 1992.

3.4 Are product certificates attached to consignments of distributed products?

Yes No

3.5 Are batch certificates attached to consignments of distributed products?

Yes No

 


4. OPINIONS OBTAINED IN THE ORGANIZATION ABOUT QUALITY ASSURANCE ISSUES IN RELATION TO DISTRIBUTED PHARMACEUTICAL PRODUCTS

4.1 Is the present system of quality assurance used by the organization considered as satisfactory?

Yes No

If No: how should it be modified?

4.2 Can the use of the WHO-type product certificates and batch certificates be expanded?

Yes No

If No: what are the difficulties?

4.3 Is the level of quality analysis of samples of distributed products (see item 2.4) considered as satisfactory?

Yes No

If No: how can it be improved?

 

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