EU GMP Guide: new Requirements added for Batch Certification
In Part III of the EU GMP Guide, a document on internationally harmonised
requirements for batch certification has been added. It is applicable in
the context of Mutual Recognition Agreements (MRA), Agreements on Conformity
Assessment and Acceptance of Industrial Products (ACAA) and other appropriate
arrangements on GMP with the European Union.
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. In the framework of the European
Union's ACAA with Israel (once in operation) all quality control sites must be
located in Israel or the EU.
The respective certificate should 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. It shall attest that the batch meets the
specifications and has been manufactured in accordance with the marketing authorisation
of the importing country. The batch certificate should be signed by the person
responsible for certifying that the batch is suitable for release for sale or supply/export.
For the EU, that the Qualified Person (QP).
Where applicable this batch certificate shall also be used for non-finished medicinal
products such as intermediates, bulk or partially packed products.
The certificate may also be used for active pharmaceutical ingredients (API) and investigational
medicinal products (IMP) used in clinical trial authorisations.