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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 4 (d): Manufacturer’s/Official Batch Certificate of a Pharmaceutical Product

Manufacturer’s/Official1 Batch Certificate of a Pharmaceutical Product

No. of Certificate........
Importing (requesting) country:

Proprietary name (if applicable) and dosage form:
Active ingredient(s)2 and amount(s) per unit dose:

Details of product licence and product certificate issued in the exporting country

Product-licence holder:

Product-licence number:

Date of issue:

Product licence issued by:

 

Product-certificate number: 3

Batch number:

Date of manufacture:

Shelf-life (years):

Contents of container:

Nature of secondary container:

Nature of primary container/wrapping:

Specific storage conditions recommended for the product:

Temperature range:

 

Quality analysis

What specifications apply to this dosage form?

Either specify the pharmacopoeia or append the specifications.

Does the batch comply in all particulars with the above specifications?

yes no

Append certificate of analysis.4


It is hereby certified that the above declarations are correct and that results of the analyses and assays on which they are based will be provided on request to the competent authorities in both the importing and the exporting countries.

Name and address of authorized person:

Signature of authorized person:

 

Stamp:

Telephone/fax numbers:

Date:

This certificate conforms to the format recommended by the World Health Organization (General instructions and explanatory notes overleaf)

General instructions

Please refer to the guidelines for further information on how to complete this form and on the implementation of the Scheme.

Forms should be completed using a typewriter to ensure legibility.

A cross should be placed in boxes as appropriate to indicate which options apply.

Additional sheets should be appended, as necessary, to accommodate remarks and explanations.

Explanatory notes

Certification of individual batches of a pharmaceutical product is only undertaken exceptionally by the competent authority of the exporting country. Even then, it is rarely applied other than to vaccines and biologicals. For other products, the responsibility for any request to provide batch certificates rests with the product-licence holder in the exporting country. The responsibility to forward certificates to the competent authority in the importing country is most conveniently assigned to the importing agent.

Any inquiries or complaints regarding a batch certificate should always be addressed to the competent authority in the exporting country. A copy should be sent to the product-licence holder.

1 Strike out whichever does not apply.

2 Use, whenever possible, International Nonproprietary Names (INNs) or national nonproprietary names.

3 This refers to the Certificate of a Pharmaceutical Product as recommended by the World Health Organization.

4 Identify and explain any discrepancies from specifications.

 

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