WHO TRS (Technical Report Series) 908, 2003 Annex 5
Model Certificate Of Good Manufacturing Practices | Annex 5
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 recommended by the World Health Organization
(general instructions and explanatory notes attached).
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
license 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:
____________________________________________________________
_________________
1. This model
certificate for GMP is not part of the WHO Certification Scheme on the Quality
of Pharmaceutical Products Moving in International Commerce.
Explanatory notes
(1) This certificate,
which is in the format recommended 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 license for the site this number should be specified. Record
“not applicable” in case where there is no legal framework for the issuing of a
license.
(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 labeling |
|
Injectables |
Cefalosporin |
Aseptic
preparation, packaging, labeling |
Example 2
|
Pharmaceutical Product(s)2 |
Category(ies) |
Activity(ies) |
|
Starting
material(s):3 |
|
|
|
Paracetamol |
Analgesic |
Synthesis,
purification, packing, labeling |
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.
__________________
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.
Model certificate of
Good Manufacturing Practices | Annex 5: