Hi there! I can’t seem to find anything in the guidelines concerning the following, but I have heard it…so I would like to confirm.
We are importer/distributor. Most of our products are manufactured in India. We have offices in India and have QA present in theses offices.
Our India QA team reviews all the documentation around the manufacturing/packaging/validation etc. Can they perform the release of the product or does this have to be performed by our Canadian based QA team?. I know the analysis must be performed in a Canadian lab… but besides that, can they release the documentation and the only release CAnada would do is analysis release?
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)
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. (04 December 2014 as appeared on the website of Health Canada)
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.
Therefore, according my understanding since India does not fall in the above group of countries, it may not be possible to perform Product Batch Release by Indian team. However, they can review the GMP Batch documents for compliance.
(Noe:- You are requested to confirm this fact by referring Regulatory authorities - Health Canada.)
1 Like