Quality Assurance of Pharmaceuticals - A Compendium of Guidelines and Related Materials - Volume 1
(1997; 248 pages) [French] View the PDF document
Table of Contents
Open this folder and view contentsIntroduction
Open this folder and view contents1. National drug regulation
Open this folder and view contents2. Product assessment and registration
Open this folder and view contents3. Distribution
Open this folder and view contents4. The international pharmacopoeia and related activities
Open this folder and view contents5. Basic tests
Open this folder and view contents6. Laboratory services
Close this folder7. International trade in pharmaceuticals
Close this folderGuidelines for implementation of the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce1
View the document1. Provisions and objectives
View the document2. Eligibility for participation
View the document3. Requesting a certificate
View the document4. Issuing a certificate
View the document5. Notifying and investigating a quality defect
View the documentReferences
View the documentAppendix 1. Model Certificate of a Pharmaceutical Product
View the documentAppendix 2. Model Statement of Licensing Status of Pharmaceutical Product(s)
View the documentAppendix 3. Model Batch Certificate of a Pharmaceutical Product
View the documentAppendix 4. Glossary and index
View the documentWorld Health Assembly resolution WHA50.3: Guidelines on the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce
View the documentGuidelines on import procedures for pharmaceutical products1
Open this folder and view contents8. Counterfeit products
Open this folder and view contents9. Training
View the documentSelected WHO publications of related interest
View the documentBack cover
 

Appendix 3. Model Batch Certificate of a Pharmaceutical Product

Manufacturer’s/Official1 Batch Certificate of a Pharmaceutical Product

This certificate conforms to the format recommended by the World Health Organization (general instructions and explanatory notes attached).

1.

No. of Certificate: ________________________________________________________

   

2.

Importing (requesting) authority: _____________________________________________

   

3.

Name of product: ________________________________________________________

   

3.1

3.1 Dosage form: ________________________________________________________

   

3.2

Active ingredient(s)2 and amount(s) per unit dose: _______________________________

 

_______________________________________________________________________

 

_______________________________________________________________________

   

3.2.1

Is the composition of the product identical to that registered in the country of export? yes/no/not applicable3 (key in as appropriate)

   
 

If no, please attach formula (including excipients) of both products.

   

4.

Product-licence holder4 (name and address):

 

______________________________________________________________________

 

______________________________________________________________________

 

______________________________________________________________________

   

4.1

4.1 Product-licence number:4 _______________________________________________

   

4.2

Date of issue:4 __________________________________________________________

   

4.3

Product licence issued by:4 ________________________________________________

   

4.4

Product-certificate number:4,5 ______________________________________________

   

5.1

Batch number: __________________________________________________________

   

5.2

Date of manufacture: _____________________________________________________

   

5.3

Shelf-life (years): ________________________________________________________

   

5.4

Contents of container: ____________________________________________________

   

5.5

Nature of primary container: _______________________________________________

   

5.6

Nature of secondary container/wrapping: _____________________________________

   

5.7

Specific storage conditions: _______________________________________________

 

______________________________________________________________________

   

5.8

Temperature range: ______________________________________________________

   

6.

Remarks:6 _____________________________________________________________

 

______________________________________________________________________

 

7.

Quality analysis

   

7.1

What specifications apply to this dosage form? Either specify the pharmacopoeia or append company specifications.7

 

______________________________________________________________________

 

7.1.1

In the case of a product registered in the exporting country, have the company specifications’ been accepted by the competent authority? yes/no (key in as appropriate)

   

7.2

Does the batch comply with all parts of the above specifications? yes/no (key in as appropriate)

   

7.3

Append certificate of analysis.8

 

It is hereby certified that the above declarations are correct and that the 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:

_____________________________________________________________________________

_____________________________________________________________________________

 

Telephone number: _______________

Fax number:_________________________________

 

Signature of authorized person: ____________________________________________________

 

Stamp and date: ________________________________________________________________

General instructions

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

These forms are suitable for generation by computer. They should always be submitted as hard copy, with responses printed in type rather than handwritten.

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, sera and biologicals. For other products, the responsibility for any requirement 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 “Not applicable” means that the product is not registered in the country of export.

4 All items under 4 refer to the product licence or the Certificate of a Pharmaceutical Product issued in the exporting country.

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

6 Indicate any special storage conditions recommended for the product as supplied.

7 For each of the parameters to be measured, the specifications give the values that have been accepted for batch release at the time of product registration.

8 Identify and explain any discrepancies from specifications. Government batch release certificates issued by certain governmental authorities for specific biological products provide additional confirmation that a given batch has been released, without necessarily giving the results of testing. The latter are contained in the manufacturer’s certificate of analysis.

The layout for this Model Certificate is available on diskette in WordPerfect from the Division of Drug Management and Policies, World Health Organization, 1211 Geneva 27, Switzerland.

to previous section
to next section
 
 
The WHO Essential Medicines and Health Products Information Portal was designed and is maintained by Human Info NGO. Last updated: March 20, 2014