International Harmonized Requirements for Batch Certification
Content of the Fabricator's/Manufacturer's Batch Certificate for Drug/Medicinal Products (Content of the Batch Certificate for Medicinal Products) Exported to Countries under the Scope of a Mutual Recognition Agreement (MRA)
NOTE: the following information supersedes the information available in Appendix 1 of GUI-0001.
In the framework of Mutual Recognition Agreements (MRA), the Sectoral Annex on Good Manufacturing Practices (GMP) requires a batch certification scheme for medicinal products covered by the pharmaceutical Annex. The internationally harmonized requirements for the content of the batch certificate of a medicinal product are provided in this document.
Each batch of medicinal product transferred between countries having appropriate arrangements on GMP, must be accompanied by a batch certificate issued by the manufacturer in the exporting country. In the framework of MRAs all manufacturing sites must be located in the country issuing the certificate or in another MRA country, if reciprocal arrangements are in force.
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. The batch 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, packaging and quality control records were reviewed and found in conformity with GMP. The batch certificate will be signed by the person responsible for certifying that the batch is suitable for release for sale or supply/export at the manufacturing site.
The importer of the batch of medicinal product is to receive and maintain the batch certificate issued by the manufacturer. It has to be available to regulatory authorities of the importing country. This certification by the manufacturer on the conformity of each batch is essential to exempt the importer from re-testing.
Where applicable this batch certificate shall also be used for non-finished medicinal products such as intermediates, bulk or partially packed products.
This certificate may also be used for investigational medicinal products used in clinical trial authorisations.
These harmonized requirements have been agreed bilaterally by Canada with the regulatory authorities of the following countries: Australia, countries of the European Economic Area - European Free Trade Association (EEA-EFTA), Member States of the European Union (EU) and Switzerland.
Content of the Batch Certificate for Medicinal Products
[ LETTER HEAD OF EXPORTING MANUFACTURER ]
- Name of product
- Importing country
- Marketing authorisation number or Clinical Trial Authorisation Number
- Dosage form
- Package size and type
- Batch number
- Date of manufacture
- Expiry date
- Name, address and authorisation number of all manufacturing sites and quality control sites
- Certificates of GMP Compliance of all sites listed under 10 or, if available, EudraGMP reference numbers
- Results of analysis
- Certification statement
- Name and position/title of person authorising the batch release
- Signature of person authorising the batch release
- Date of signature
Explanatory Notes and Glossary
Glossary of equivalent terms used in the Certificate template (non-exhaustive)
- batch = lot
- dosage form = pharmaceutical form
- manufacturer = fabricator
- manufacturing/manufacture = fabrication
- manufacturing authorisation = establishment licence
- medicinal product = pharmaceutical product = drug product
- quality control = testing
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