Internationally Harmonized Requirements for Batch Certification
In the framework of Mutual Recognition Agreements, the Sectoral Annex
on Good Manufacturing Practices (GMP) requires a batch certification scheme
for drug/medicinal products covered by the pharmaceutical Annex. The internationally
harmonised requirements for the content of the batch certificate of a
drug/medicinal product is attached. The importer of the batch is to receive
and maintain the batch certificate issued by the fabricator/manufacturer.
Upon request, it has to be readily available to the staff of the Regulatory
Authority of the importing country. This certification by the manufacturer
on the conformity of each batch is essential to exempt the importer from
re-control (re-analysis).
Each batch transferred between countries having an MRA in force, must
be accompanied by a batch certificate issued by the fabricator/manufacturer
in the exporting country. This certificate will be issued further to a
full qualitative and quantitative analysis of all active and other relevant
constituents to ensure that the quality of the products complies with
the requirements of the Marketing Authorisation of the importing country.
This certificate will attest that the batch meets the specifications and
has been manufactured in accordance with the Marketing Authorisation of
the importing country, detailing the specifications of the product, the
analytical methods referenced, the analytical results obtained, and containing
a statement that the batch processing and packaging quality control records
were reviewed and found in conformity with GMP. The batch certificate
will be signed by the person responsible for releasing the batch for sale
or supply/export at the fabrication/manufacturing site.
These harmonised requirements have been agreed by the Regulatory Authorities
of the following parties/countries: Australia, Canada, European Community,
New Zealand and Switzerland.
Content of the Fabricator's/Manufacturer's
Batch Certificate
for Drug/Medicinal Products Exported to Countries
under the Scope of a Mutual Recognition Agreement (MRA)
[ LETTER HEAD OF EXPORTING MANUFACTURER ]
1. Name of product
Proprietary, brand or trade name in the importing country.
2. Importing Country
3. Marketing Authorization Number
The marketing authorisation number of the product in the importing country
should be provided.
4. Strength/Potency
Identity (name) and amount per unit dose required for all active ingredients/constituents.
5. Dosage form (pharmaceutical form)
6. Package size (contents of container) and type (e.g. vials, bottles,
blisters)
7. Lot/batch number
As related to the product.
8. Date of fabrication/manufacture
In accordance with national (local) requirements.
9. Expiry date
10. Name and address of fabricator(s)/manufacturer(s) - manufacturing
site(s)
All sites involved in the manufacture including packaging and quality
control of the batch should be listed with name and address. The name
and address must correspond to the information provided on the Manufacturing
Authorisation/Establishment Licence.
11. Number of Manufacturing Authorisation / Licence or Certificate of
GMP Compliance of a manufacturer/fabricator
Number should be given for each site listed under item 10.
12. Results of analysis
Should include the authorized specifications, all results obtained and
refer to the methods used (may refer to a separate certificate of analysis
which must be dated, signed and attached).
13. Comments/remarks
Any additional information that can be of value to the importer and/or
inspector verifying the compliance of the batch certificate (e.g. specific
storage or transportation conditions).
14. Certification statement
This statement should cover the fabrication/manufacturing, including
packaging and quality control. The following text should be used: "I
hereby certify that the above information is authentic and accurate. This
batch of product has been fabricated/manufactured, including packaging
and quality control at the above mentioned site(s) in full compliance
with the GMP requirements of the local Regulatory Authority and with the
specifications in the Marketing Authorisation of the importing country.
The batch processing, packaging and analysis records were reviewed and
found to be in compliance with GMP".
15. Name and position/title of person authorizing the batch release
Including its company/site name and address, if more than one company
is mentioned under item 10.
16. Signature of person authorizing the batch release
17. Date of signature
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