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WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 908 - Thirty-seventh Report
(2003; 148 pages) View the PDF document
Table of Contents
View the documentWHO Expert Committee on Specifications for Pharmaceutical Preparations
View the document1. Introduction
Open this folder and view contents2. General policy
Open this folder and view contents3. Quality control - specifications and tests
View the document4. Quality control - international reference materials
Open this folder and view contents5. Quality control - national laboratories
Open this folder and view contents6. Quality assurance - good manufacturing practices
Open this folder and view contents7. Quality assurance - inspection
Open this folder and view contents8. Quality assurance - distribution and trade-related
Open this folder and view contents9. Quality assurance - risk analysis
Open this folder and view contents10. Quality assurance - drug supply
Open this folder and view contents11. Quality assurance - storage
View the document12. International Nonproprietary Names (INNs) programme
Open this folder and view contents13. Miscellaneous
View the documentAcknowledgements
View the documentReferences
View the documentAnnex 1 Recommendations on risk of transmitting animal spongiform encephalopathy agents via medicinal products
View the documentAnnex 2 The International Pharmacopoeia: revised concepts and future perspectives
Open this folder and view contentsAnnex 3 Guidelines on Good Manufacturing Practices for radiopharmaceutical products
Open this folder and view contentsAnnex 4 Good Manufacturing Practices for pharmaceutical products: main principles
View the documentAnnex 5 Model certificate of Good Manufacturing Practices
View the documentAnnex 6 Guidance on Good Manufacturing Practices (GMP): inspection report
View the documentAnnex 7 Application of Hazard Analysis and Critical Control Point (HACCP) methodology to pharmaceuticals
Open this folder and view contentsAnnex 8 Procedure for assessing the acceptability, in principle, of pharmaceutical products for purchase by United Nations agencies
Open this folder and view contentsAnnex 9 Guide to good storage practices for pharmaceuticals1
View the documentBack cover
 

Annex 5 Model certificate of Good Manufacturing Practices

© World Health Organization
WHO Technical Report Series, No. 908, 2003

A model certificate of Good Manufacturing Practices (GMP) for a manufacturing site is suggested (see below). This is not part of the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce but is intended to serve in situations where a specific GMP certificate is requested by importers, exporters, procurement agencies and regulatory authorities. It is suggested that the certificate should remain valid for a period of 2 years from the date of issue, but not exceeding 3 years after the inspection was carried out.

It is recommended that, where possible, GMP certificates should have, e.g. security seals, watermarks or holograms, to help prevent counterfeiting, tampering and other fraudulent activities.

Letterhead of regulatory authority

Model Certificate of Good Manufacturing Practices

This one-page certificate conforms to the format recommeded by the World Health Organization (general instructions and explanatory notes attached).1

1 This model certificate for GMP is not part of the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce.


Certificate No: ______________________________________________

On the basis of the inspection carried out on ____ [date] ____ we certify that the site indicated on this certificate complies with Good Manufacturing Practices for the dosage forms, categories and activities listed in Table 1.

1. Name and address of site:

____________________________________________________________

2. Manufacturer’s licence number:

____________________________________________________________

3. Table 1:

Dosage form(s)

Category(ies)

Activity(ies)

     

The responsibility for the quality of the individual batches of the pharmaceutical products manufactured through this process lies with the manufacturer.

This certificate remains valid until ____ [date] ____ It becomes invalid if the activities and/or categories certified herewith are changed or if the site is no longer considered to be in compliance with GMP.

Address of certifying authority:

____________________________________________________________

Name and function of responsible person:

____________________________________________________________

Email: __________ Telephone no.: __________ Fax no.: ______________

Signature:

Stamp and date:

____________________________________________________________

Explanatory notes

(1) This certificate, which is in the format recommeded by WHO, certifies the status of the Site listed in point 1 of the certificate.

(2) The certification number should be traceable within the regulatory authority issuing the certificate.

(3) Where the regulatory authority issues a licence for the site this number should be specified. Record “not applicable” in case where there is no legal framework for the issuing of a licence.

(4) Table 1

List the dosage forms, starting materials, categories and activities. Examples give below.

Example 1

Pharmaceutical Product(s)2

Category(ies)

Activity(ies)

Dosage form(s):

   

Tablets

Cytotoxic

Packaging

 

Hormone

Production, packaging, quality control

 

Penicillin

Repackaging and labelling

Injectables

Cefalosporin

Aseptic preparation, packaging, labelling

Example 2

Pharmaceutical Product(s)2

Category(ies)

Activity(ies)

Starting material(s):3

   

Paracetamol

Analgesic

Synthesis, purification, packing, labelling

 

2 Pharmaceutical Products: Any medicine intended for human use or veterinary product administered to food-producing animals, presented in its finished dosage for or as a starting material for use in such a dosage form, that is subject to control by pharmaceutical legislation in both the exporting state and the importing state.

3 Starting Materials: Any substance of a defined quality used in the production of a pharmaceutical product, but excluding packaging materials.


Use, whenever available, International Nonproprietary Names (INNs) or otherwise national nonproprietary names.

(5) The certificate remains valid until the specified date. The certificate becomes invalid if the activities and/or categories certified are changed or if the site is no longer considered to be in compliance with GMP.

(6) The requirements for good practices in the manufacture and quality control of drugs referred to in the certificate are those included in Quality Assurance of Pharmaceuticals: a compendium of guidelines and related materials. Good manufacturing practices and inspection, Volume 2, 1999. World Health Organization, Geneva and subsequent updates.

 

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